WHILL Model F

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 7, 2022 Whill, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K221438 Trade/Device Name: WHILL Model F Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 16, 2022 Received: May 17, 2022 Dear Prithul Bom: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221438 Device Name WHILL Model F Indications for Use (Describe) The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY ## K221438 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: | SUBMITTER | Whill, Inc. | |-----------|------------------------------------------------------| | | 2-1-11 Higashi-Shinagawa; Harbor Premium Building 2F | | | Shinagawa-ku, Tokyo 140-0002 Japan | | | Phone: +819025672984 | | | Contact Person: Tsuyoshi Iriyama | | | Date Prepared: April 15, 2022 | #### DEVICE II. | Name of Device: | WHILL Model F | |------------------------------|-------------------| | Classification Name: | Physical Medicine | | Regulation: | 21 CFR § 890.3860 | | Regulatory Class: | Class II | | Product Classification Code: | ITI | #### III. PREDICATE DEVICE Primary Predicate Device - Manufacturer: Whill, Inc. - Trade Name: WHILL Model C2 ● - 510(k): K213383 - Classification Name: Physical Medicine - Regulation: 21 CFR § 890.3860 ● - Regulatory Class: Class II ● - . Product Classification Code: ITI #### IV. REFERENCE DEVICE 1 #### Reference Device 1 - Manufacturer: Nanjing Jin Bai He Medical Apparatus Co. Ltd. - Trade Name: Powered Wheelchair DYW30A(D09) - 510(k): K170787 ● - Classification Name: Physical Medicine - Regulation: 21 CFR § 890.3860 - Regulatory Class: Class II ● - Product Classification Code: ITI {4}------------------------------------------------ #### V. DEVICE DESCRIPTION The subject device is an update to the existing previously cleared WHILL Model C2 (K213383) (hereafter the "predicate device"). The WHILL Model F is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It has two arm rests, a seat belt, a foldable backrest, a seat cushion, a foldable frame, two motors, two electromagnetic brakes, an electric motor controller, and a lithium-ion battery with a dedicated off-board battery charger. The wheelchair is powered by a 25.3 V DC 10.6A rechargeable lithium-ion battery charged by an off-board lithium-ion battery charger. The control system, including the directional controller (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. As with all conventional powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the arm rests to fit the user's body. The space between the two arms and the height of the arm rests can be adjusted based on the user's seating requirements. Model F contains a new folding feature, not available on the predicate device. The foldable technology is like the legally marketed DYW30A(D09) powered wheelchair (K170787) (hereafter the "reference device"). The subject device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app can also display the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key. The device supports a maximum weight of 253.5lb (115 kg), including the weight of the occupant and any carried items. It has a maximum driving range of 12.4 miles (20 km) with a maximum speed limit of up to 3.7mph (6 km/h). #### INDICATIONS FOR USE VI. The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE VII. DEVICE {5}------------------------------------------------ The indications for use, design, and function of the subject device are identical to the primary predicate device WHILL Model C2 (K213383). The following characteristics were compared between the subject device and the predicate devices to demonstrate substantial equivalence: - о Indications for Use: WHILL Model F has the same indications of use, principles of operation, and mostly identical technical characteristics as the previously cleared primary predicate device, WHILL Model C2 (K213383). Both are indicated for indoor and outdoor mobility to persons limited to a seated position capable of operating a powered wheelchair. - Materials: The subject device shares identical materials used in surface contacting O components as the primary predicate device. All the subject device's surface-contacting parts are tested to ISO 10993standard. - Design: The subject device uses the same technology as the primary predicate device. The O key differences are that the subject device can be folded for storage and transportation, uses casters as the front-wheels drive and does not have suspension system on its rear drive wheels. These key features have been evaluated for safety and performance and tested to ISO 7176 standard. The testing demonstrates that the differences do not raise new questions of safety or effectiveness. - Energy Source: The subject device and the primary predicate share identical batteries. The O Lithium-ion battery used in the subject device has been safety tested to IEC 62133-2 standard. - Performance Testing: Both the predicate and subject devices were subjected to the same O biocompatibility and performance tests listed below in Section-IX. #### VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE REFERENCE DEVICE 1 The subject device can be folded for storage and transportation. Hence Powered Wheelchair-DYW30A(D09) (K170787) manufactured by Nanjing Jin Bai He Medical Apparatus is chosen as the reference device 1 to account for this design feature. - Indications for Use: WHILL Model F has similar indications of use, principles of operation, o and similar technical characteristics as the reference device 1, Powered Wheelchair DYW30A(D09) (K170787). Although there is a minor difference in the indications of use, the primary indication of both the subject device and the reference device 1 is to assist with mobility to users limited to a seated position who can operate and control the powered wheelchair. - Materials: The subject device has more surface contacting components tested to ISO 10993 o standard. There is no detail on the surface contacting components and biocompatibility test of the reference device 1 in its 510(k) summary. - Energy Source: The subject device and the reference device 1 are both powered by a O lithium- ion battery. The lithium-ion battery used in the subject device has been safety tested to IEC62133-2 standard. - Performance Testing: Both the reference device 1 and subject devices were subjected to O the same performance tests listed below in Section-IX. {6}------------------------------------------------ #### SAFETY AND PERFORMANCE DATA IX. The following performance data were provided in support of the substantial equivalence determination. (Table 1 Table 2 Table 3 ) ## Sterilization & Shelf-life Testing: The device is provided and used non-sterile. There are no parts that can expire, and thus, there is no shelf life. ### Non-clinical performance testing: The subject device, primary predicate, reference device 1 were tested to the ISO 7176 standard. These standards are listed in the FDA document entitled "Guidance Document for the Preparation of Premarket Notification [510k]] Applications for Mechanical and Powered Wheelchairs and Motorized Three-Wheeled Vehicles." {7}------------------------------------------------ | Subject Device<br>WHILL Model F | Primary Predicate Device<br>WHILL Model C2 (K213383) | Reference Device 1<br>Powered Wheelchair | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | ISO 7176-1 Third edition 2014-10-01 Wheelchairs -Part 1:<br>Determination of static stability | Identical to subject device | Identical to subject device | | ISO 7176-2 Third edition 2017-10 Wheelchairs - Part<br>2:Determination of dynamicstability of electrically powered<br>wheelchairs | Identical to subject device | ISO 7176-2:2001 Wheelchairs - Part 2:Determination of<br>dynamicstability of electric wheelchairs | | ISO 7176-3 Third edition 2012-12-15 Wheelchairs -Part 3:<br>Determination of effectiveness of brakes | Identical to subject device | Identical to subject device | | ISO 7176-4 Third edition 2008-10-01Wheelchairs - Part 4: Energy<br>consumptionof electric wheelchairs and scooters for<br>determination of theoretical distance range | Identical to subject device | Identical to subject device | | ISO 7176-5 Second edition2008-06-01Wheelchairs - Part 5:<br>Determination of overall dimensions, mass and maneuvering<br>space | Identical to subject device | Identical to subject device | | ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6:<br>Determination of maximum speed, acceleration and deceleration<br>of electric wheelchairs | Identical to subject device | ISO 7176-6:2001 Wheelchairs - Part 6: Determination of<br>maximum speed, acceleration and deceleration of electric<br>wheelchairs | | ISO 7176-8 Second edition 2014-12-15 Wheelchairs - Part 8:<br>Requirements and test methods for static, impact and fatigue<br>strengths | Identical to subject device | Identical to subject device | | ISO 7176-9 Third edition 2009-11-15Wheelchairs - Part 9: Climatic<br>tests for electric wheelchairs | Identical to subject device | Identical to subject device | | ISO 7176-10 Second edition 2008-11 01Wheelchairs - Part 10:<br>Determination of obstacle-climbing ability of electrically powered<br>wheelchairs | Identical to subject device | Identical to subject device | | ISO 7176-11 Second edition 2012-12-01Wheelchairs - Part 11: Test<br>dummies | Identical to subject device | Identical to subject device | | Subject Device | Primary Predicate Device | Reference Device | | WHILL Model F | WHILL Model C2 (K213383) | Powered Wheelchair DYW30A(D09) (K170787) | | ISO 7176-13: 1989<br>Wheelchairs - Part 13: Determination of Coefficientof Friction of Test<br>Surfaces | Identical to subject device | Identical to subject device | | ISO 7176-14 Second edition2008-02-15 Wheelchairs - Part 14: Power<br>and control systems for electrically powered wheelchairs and scooters<br>- Requirements and test methods | Identical to subject device | Identical to subject device | | ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15:<br>Requirements for information disclosure, documentation and labeling | Identical to subject device | Identical to subject device | | ISO 7176-16 Wheelchairs -Part 16: Resistance to ignition of postural<br>supportdevices- ISO 8191-2:1988Furniture - Assessmentof<br>ignitability of upholstered furniture —Part 2: Ignition source:<br>match-flame equivalent | Identical to subject device | Identical to subject device | | ISO 7176-21 Second edition2009-04-01Wheelchairs - Part 21:<br>Requirements and test methods for electromagnetic compatibility of<br>electrically powered wheelchairs and scooters, and battery chargers | Identical to subject device | Identical to subject device | | ISO 7176-22 Second edition2014-09-01 Wheelchairs - Part 22: Set-up<br>procedure | Identical to subject device | N/A | | UN 38.3 Recommendationsof the TRANSPORT OF DANGEROUS<br>GOODS,<br>Manual of Test and Criteria,Part III, Lithium metal and lithium-ion<br>batteries | Identical to subject device | N/A | {8}------------------------------------------------ {9}------------------------------------------------ ## Biocompatibility Testing Biocompatibility assessment of patient-contacting components in the subject device was performed in conformance with ISO 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. Table 2 Biocompatibility Testing | Test Standard | Acceptance criteria | Result | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--------------| | ISO 10993-5:2009, Biological Evaluation of<br>Medical Devices - Part 5: Tests For In Vitro<br>Cytotoxicity | Non- Cytotoxic | Pass | | ISO 10993-10:2010 Biological Evaluation of Medical<br>Devices - Part 10: Tests for Irritation andSkin<br>Sensitization | Non-Sensitizing<br>Non-irritating | Pass<br>Pass | ## Electrical Safety and Electromagnetic Compatibility testing Electrical Safety and Electromagnetic Compatibility testing was performed on a sample of battery and battery chargers in the subject device and found to conform with the following test standards. | Test Standard | Test description | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-2 Edition 4.0 2014-02 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic<br>Safety and Essential Performance - Collateral Standard: Electromagnetic<br>Disturbances - Requirements and Tests | | IEC/EN 61000-3-2:2014 | Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic<br>current emissions (equipment input current ≤ 16 A per phase) | | IEC/EN 61000-3-3:2013 | Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage<br>changes, voltage fluctuations and flicker in public low-voltage supply<br>systems, for equipment with rated current ≤16 A per phase and not subject<br>to conditional connection | | IEC/EN61000-4-2 Edition 2.0 2008-12 | Electromagnetic compatibility (EMC)- Part 4-2: Testing and measurement<br>techniques – Electrostatic discharge immunity test | | IEC/EN61000-4-3 Edition 3.2 2010-04 | Electromagnetic compatibility (EMC)- Part 4-3: Testing and measurement<br>techniques - Radiated, radiofrequency, electromagnetic field immunity test | | IEC/EN61000-4-4 Edition 3.0 2012-04 | Electromagnetic compatibility (EMC) Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test (EFT) | | IEC/EN61000-4-5 Edition 3.1 2017-08 | Electromagnetic compatibility (EMC) Part 4-5: Testing and measurement techniques - Surge immunity test | | IEC/EN61000-4-6 Edition 4.0 2013-10 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields | | IEC/EN61000-4-8 Edition 2.0 2009-09 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test | | IEC/EN61000-4-11 Edition 2.1 2017-05 | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests | | EN 61326-2-2:2013 | Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems | | EN 61326-1:2013 | EMC Emissions/Immunity Requirement Changes for Laboratory Equipment | | ETSI EN 301 489-1 V2.2.3 (2019-11) | Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonized Standard for Electromagnetic Compatibility | | ETSI EN 300 328 V2.2.2 (2019-07) | Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques | | FCC 47 CFR 15 Subpart B | Unintentional Radiators | | IEC 62368-1:2018 | Hazard-based electrical safety standard for IT equipment and Audio-Visual products | | IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and batteries made from them, for use in portable applications - Part 2: Lithium systems | #### Table 3 EMC and Electrical Safety Testing {10}------------------------------------------------ ## Software Verification and Validation Testing Software Verification and Validation Testing was conducted per the requirements of ANSI AAMI IEC 62304:2006/A1:2015. Level of Concern: The Level of Concern for the subject device software is moderate. This determination is based on answering the questions in the FDA Guidance Document "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. {11}------------------------------------------------ ### FCC Radio Frequency Testing The Radiofrequency wireless technology was tested to FCC requirements and found to comply with 47 CFR 15.249. ### Wireless Co-existence Testing: The performance of WHILL Model F was evaluated in an environment with other WHILL Model F devices and with different types of 2.4 GHz wireless devices. The device met all specified in ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence. ### Usability Testing Usability was validated following IEC 62366-1:2015. Mechanical and acoustic TestingNot Applicable. #### Animal Study Animal performance testing was not required to demonstrate the safety and effectiveness of thedevice. ### Human Clinical Performance Testing Clinical testing was not required to demonstrate the safety and effectiveness of the device #### X. CONCLUSIONS The July 28, 2014 FDA Guidance entitled "The 510|| Program: Evaluating Substantial Equivalence in Premarket Notfjications [510(k)]" was used to determine substantial equivalence. The WHLL Model F (Subject Device) described herein intended use and the same fundamental technology as the cleared primary predicate device, the WHILL Model C2 (K213383), and the reference device, Powered Wheelchair DY W30A(D09) (K170787), Based on the performance data presented for the subject device and primary predicate device, it can be concluded that the WHLL Model F is as safe and substantially equivalent to both the predicate device and the reference device. {12}------------------------------------------------ | Device | Subject Device<br>WHILL Model F | Primary Predicate Device<br>WHILL Model C2 (K213383) | Reference Device 1<br>Powered Wheelchair<br>DYW30A(D09) (K170787) | Remark | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Whill, Inc. | Whill, Inc. | Dongguan Prestige Sporting<br>Goods Co., Ltd | Same | | 510K Number | Unknown | K213383 | K170787 | - | | Common or Usual<br>Name | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Same | | Product Code | ITI | ITI | ITI | Same | | Product<br>Classification | Class II | Class II | Class II | Same | | Classification Name | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Same | | Regulation Number | 21 CFR 890.3860 | 21 CFR 890.3860 | 21 CFR 890.3860 | Same | | INDICATIONS FOR USE | | | | | | Indications for Use | The intended use of the Model F powered<br>wheelchair is to provide outdoor and indoor<br>mobility to persons limited to a seated position<br>that are capable of operating a powered<br>wheelchair. | The intended use of the Model C2 powered<br>wheelchair is to provide outdoor and indoor<br>mobility to persons limited to a seated position<br>that are capable of operating a powered<br>wheelchair. | The device is a motor-driven, and<br>indoor transportation vehicle with<br>the intended use to provide<br>mobility to a disabled or an<br>elderly person limited to a seated<br>position. | -Same as the primary<br>predicate<br>-Similar to Reference<br>Device. The primary<br>indication of the<br>subject and the<br>Reference Device is to<br>assist users with<br>mobility | | Type of Use | Over the Counter (OTC Only) | Over the Counter (OTC Only) | Over the Counter (OTC Only) | Same | | PHYSICAL CHARACTERISTICS COMPARISON | | | | | | | Image: WHILL Model F | Image: WHILL Model C2 | Not available | | | Device Construction | Solid aluminium frame | Solid aluminium frame | 6063 Aluminium Alloy | Same as primary<br>predicate | | Device weight | 58.9 lbs. | 114 lbs. | Not available | SE-Note 1 | | Device Length | 36.8" | 38.8" | 37.4" | SE-Note 1 | | Device Width | 21.8"-23.8" | 21.8" | 22.6" | SE-Note 1 | | Device Height | 31.6" | 29.3 - 37.2" | 36.2" | SE-Note 1 | | Number of wheels | 4 | 4 | 4 | same | | Front Wheel<br>Diameter | 7.6" (194 mm) | 10.11" | Not available | SE-Note 2 | | Rear Wheel<br>Diameter | 8.25" | 10.43" | Not available | SE-Note 2 | | Ground Clearance | 2.4" | 3" | Not available | Similar. The minor<br>difference does not<br>affect the safety and<br>effectiveness of the<br>device | | Battery pack | 1 rechargeable lithium-ion battery<br>Ratings: 25.3 V 10.5Ah | 1 rechargeable lithium-ion battery<br>Ratings: 25.3 V 10.5Ah | 2 rechargeable lithium-ion battery<br>Ratings: 24V 6AH | Same as the predicate<br>device. | | Charger | Type: off-board<br>Rated DC output voltage: 28.49V DC<br>Rated current output: 2.4A DC | Type: off-board<br>Rated DC output voltage: 28.49V DC<br>Rated current output: 2.4A DC | Type: off-board<br>Rated DC output voltage: 24V DC<br>Rated current output: 2A DC | Same as the predicate<br>device | | Battery Type | Lithium-ion | Lithium-ion | Lithium-ion | Same | | Battery weight | 6.0 lbs. | 6.0 lbs. | 17.6 lbs. (8 kg) | Same as the primary<br>predicate and lighter<br>than the Reference<br>Device 1 | | OPERATING CHARACTERISTICS | | | | | | Operating<br>environments | Indoor/outdoor uses | Indoor/outdoor uses | Indoor use | Same as the primary<br>predicate. The device<br>is Designed for indoor<br>and outdoor use.<br>Based on the testing as<br>mentioned in SE-Note<br>1 , SE-Note 2 , the<br>device poses no safety<br>and effectiveness<br>concerns. | | Maximum Weight<br>Capacity | 253lb (115 kg) | 300lb (136kg) | 220lb (100 kg) | SE-Note 5 | | Maximum speed | 3.7 mph | 5 mph | 3.75 mph (6 km/h) | SE-Note 5 | | forward | | | | | | Braking System | Electromagnetic | Electromagnetic | Electromagnetic | Same | | Turning Radius | 30.7" | 30" | 32.5" | SE-Note 1 | | Obstacle Climbing<br>Height | 1.4" | 2" | 1.36" (34.5 mm) | SE-Note 1 | | Drive system | 2 Wheel Drive (Rear wheel drive) | 2 Wheel Drive (Rear wheel drive) | 2 Wheel Drive (Rear wheel drive) | Same | | Dynamic Stability<br>(incline)/Maximum<br>allowable<br>inclination | 10° | 10° | Not available | Same | | Driving Range (full<br>battery charge) | 12.4 miles | 11 miles | 17.18 miles (27.65 km) | SE-Note 5 | | On/Off Button | Yes, Power Button on the control pad. | Yes, Power Button on the control pad. | Not available | Same | | Speed Settings | 4 | 4 | Not available | Same | | Battery Charging<br>Time | ~5 hours | ~5 hours | 6~8 hours | Same as the primary<br>predicate device. The<br>Subject device charges<br>faster than the<br>Reference Device 1. | | DESIGN FEATURES | | | | | | Motor | Manufacturer: NIDEC<br>Motor type: brushless DC motor<br>Rated output: 150W x 2 PCS | Manufacturer: NIDEC<br>Motor type: brushless DC motor<br>Rated output: 150W x 2 PCS | Not Applicable | Motor type and<br>Rated output is<br>same. Physical size is<br>smaller and lighter<br>than the predicated<br>device.<br>Subjective device<br>were conducted<br>same ISO7176 series<br>test and those<br>results show the<br>differences do not<br>raise any safety<br>issues. | | Motor controller | Manufacturer: WHILL | Manufacturer: WHILL | Not Available | Same enclosure and | | | Model: 21-00011-0 | Model: 21-00011-0 | | similar software | | Joystick Location | Left or right arm | Left or right arm | Left or right arm | Same | | User control<br>interface | User controls are housed in a single component-<br>the control pad subassembly. The control pad | User controls are housed in a single component-<br>the control pad subassembly. The control pad | Not Available | Same enclosure and<br>similar software. | {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ | | subassembly may be placed on either the right- or<br>left-hand side of the device to match the user's<br>preference.<br><br>The control pad subassembly contains the input<br>elements shown below.<br><br>Image: Control pad subassembly<br><br><b>1</b> Speed select button “-”<br>Decreases the maximum speed.<br><b>2</b> Power button<br>Turns on/off the device.<br><b>3</b> Sound button<br>Turns on/off the sound.<br><b>4</b> Joystick<br>Controls the forward, backward, left, and right<br>movements. The degree of joystick inclination<br>can also control acceleration and deceleration.<br><b>5</b> Speed select button “+”<br>Increases the maximum speed.<br><b>6</b> Display | subassembly may be placed on either the right- or<br>left-hand side of the device to match the user's<br>preference.<br><br>The control pad subassembly contains the input<br>elements shown below.<br><br>Image: Control pad subassembly<br><br><b>1</b> Speed select button “-”<br>Decreases the maximum speed.<br><b>2</b> Power button<br>Turns on/off the device.<br><b>3</b> Sound button<br>Turns on/off the sound.<br><b>4</b> Joystick<br>Controls the forward, backward, left, and right<br>movements. The degree of joystick inclination<br>can also control acceleration and deceleration.<br><b>5</b> Speed select button “+”<br>Increases the maximum speed.<br><b>6</b> Display | | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------…