Power Wheelchair, W5521

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November 9, 2023 Zhejiang Innuovo Rehabilitation Devices Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China Re: K231508 Trade/Device Name: Power Wheelchair, W5521 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 25, 2023 Received: May 25, 2023 Dear Ivy Wang: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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. # Tushar Bansal -S for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological {2}------------------------------------------------ and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231508 Device Name Power Wheelchair, W5521 Indications for Use (Describe) The Power Wheelchair, W5521, is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | 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." {4}------------------------------------------------ # 510(k) Summary ## K231508 #### l. SUBMITTER Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd. Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China Name of contact person: Grace Li Telephone: +86 15924234767 Fax: +86-579-89327232 Email: Lss@kf-innuovo.com Date prepared: 2023-11-08 #### II. Device Device trade name: Power Wheelchair, W5521 Common name: Power Wheelchair Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI #### III. Predicate device K220747 Power Wheelchair, N5515B Zhejiang Innuovo Rehabilitation Devices Co., Ltd. #### IV. Device description This Power wheelchair, W5521, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger. {5}------------------------------------------------ The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6.2 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized. ### V. Indication for use The Power Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | Attribute | Subject device | Predicate device | Discussion/<br>Conclusion | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Zhejiang Innuovo<br>Rehabilitation Devices Co.,<br>Ltd. | Zhejiang Innuovo<br>Rehabilitation Devices<br>Co., Ltd. | / | | Proprietary name,<br>model | Power Wheelchair, W5521 | Power Wheelchair,<br>N5515B | / | | 510(k) number | K231508 | K220747 | / | | Device classification<br>name | Class II | Class II | Same | | Classification<br>regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same | | Product code | ITI | ITI | Same | | Similarities | | | | | Indication for use | The Power Wheelchair is a<br>motor driven, indoor and<br>outdoor transportation<br>vehicle with the intended use<br>to provide mobility to a<br>disabled or elderly person<br>limited to a seated position. | The Power Wheelchair is<br>a motor driven, indoor<br>and outdoor<br>transportation vehicle<br>with the intended use to<br>provide mobility to a<br>disabled or elderly<br>person limited to a seated<br>position. | Same | | Intended user | disabled people with mobility<br>difficulties and elderly people | disabled people with<br>mobility difficulties and<br>elderly people | Same | | Attribute | Subject device | Predicate device | Discussion/<br>Conclusion | | Use condition | indoor and outdoor use | indoor and outdoor use | Same | | Number of wheels | 6, including two front wheels<br>and two rear wheels, two<br>anti-tip wheels | 6, including two front<br>wheels and two rear<br>wheels, two anti-tip<br>wheels | Same | | Function of wheels | Front wheels: driven wheels<br>suitable for rotation,<br>acceleration, retrograde<br>Rear wheels: driving wheels<br>to control the speed and<br>direction<br>Anti-tip wheels: preventing<br>the wheelchair from tipping<br>turning over when driving on<br>the slope. Non-adjustable. | Front wheels: driven<br>wheels suitable for<br>rotation, acceleration,<br>retrograde<br>Rear wheels: driving<br>wheels to control the<br>speed and direction<br>Anti-tip wheels:<br>preventing the<br>wheelchair from tipping<br>turning over when driving<br>on the slope.<br>Non-adjustable. | Same | | Movement control<br>method | By Joystick control | By Joystick control | Same | | Driving system | Direct drive on the rear<br>wheels | Direct drive on the rear<br>wheels | Same | | Brake system | Automatic<br>electromagnetic<br>brake system | Automatic<br>electromagnetic<br>brake system | Same | | Battery charger | Off-board charger<br>Input: 100-240V, 50/60Hz,<br>1.5A,<br>Output: 24 Vdc, 2A; | Off-board charger<br>Input: 100-240V,<br>50/60Hz, 1.5A,<br>Output: 24 Vdc, 2A; | Same | | back cushion | Polyester fabric | Polyester fabric | Same | | seat cushion | rubber patch cloth and<br>Oxford fabric | rubber patch cloth and<br>Oxford fabric | Same | | Armrest | Polyurethane (PU) | Polyurethane (PU) | Same | | Max loading weight | 136kg (≈300 lbs) | 136kg (≈300 lbs) | Same | | Maximum obstacle<br>climbing | 40 mm | 40 mm | Same | | Differences | | | | | Main frame material | aluminum alloy | Carbon fiber material | Different material used<br>for frame, that such<br>difference will not impact | | Attribute | Subject device | Predicate device | Discussion/Conclusion | | Total mass | 25kg | 16kg | subject device as the performance tests are conducted according to ISO 7176 series.<br>Different frame material caused different weight of the wheelchair. This difference will not raise any new safety and effectiveness concerns. | | Overall Dimension (length*width*height) | 1040mmX600mmX1020mm | 940mmX610mmX960mm | Minor difference on wheelchair dimension | | Stowage Dimension (length*width*height) | 390mmX600mmX810mm | 720mmX310mmX610mm | will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. | | Front wheel size/type | 7.8" x 1.9"/ PU Solid tire | 7" x 1.75"/PU Solid tire | Minor difference on dimension of driven wheel will not cause different performance. | | Rear wheel size/type | 11.8" x 2.2"/ PU Solid tire | 8.5"x 2"/ PU Solid tire | | | Max speed forward | Up to 5.47 km/h (1.52 m/s), adjustable | Up to 6 km/h (1.6 m/s), adjustable | minor difference on max. forwarding speed will not cause different performance. lower speed will be more safety. | | Max Speed backward | Less than 3 km/h (0.9m/s) | Less than 3 km/h (0.5m/s) | minor difference on max. back warding speed will not cause different performance. | | Maximum safe operational incline degree | 6° | 9° | minor difference on safe operational incline degree will not cause new safety and effectiveness concerns are raised as both the static and dynamic stability under specific inclining degree have been evaluated | | Attribute | Subject device | Predicate device | Discussion/Conclusion | | | | | according to standard<br>ISO 7176 series. | | Braking distance | ≤1 m | ≤1.5 m | minor difference on<br>braking distance will not<br>cause different<br>performance. Shorter<br>distance for braking will<br>be more safety. | | Battery | li-ion battery pack;<br>rechargeable, 24 VDC 10Ah | li-ion battery pack;<br>rechargeable, 24 VDC 12Ah | minor difference on<br>battery capacity will not<br>cause different<br>performance. This<br>difference will not raise<br>any new safety and<br>effectiveness concerns. | | Maximum distance<br>of travel on the fully<br>charged battery | 10km | 15 km | Minor difference on<br>travel distance will not<br>cause different<br>performance. This<br>difference will not raise<br>any new safety and<br>effectiveness concerns | | Motor | Brush DC motor; 24VDC;<br>200W; 2pcs | Brushless DC motor;<br>24VDC; 250W; 2pcs | minor difference on<br>motor power will not<br>cause different<br>performance. Both of<br>the motors are<br>evaluated according to<br>standard ISO<br>7176-14:2008 and there<br>are no new safety and<br>effectiveness concerns<br>raised due to the<br>difference. | | Electronic controller | Micon M7086 controller | Micon M7084 controller | Similar controller is<br>used, both the control<br>system, including the<br>joystick controller, the<br>electromagnetic brakes<br>and the user interface<br>are similar. The joystick<br>controls the directions | | Attribute | Subject device | Predicate device | Discussion/<br>Conclusion | | | | | | | | | | and speed of<br>movement, and when<br>the joystick is released,<br>the powered wheelchair<br>will slow down to stop<br>and the brakes will<br>automatically<br>re-engage. The<br>controller also provides<br>the battery status<br>displaying and abnormal<br>condition displaying.<br>Both of the control<br>systems are evaluated<br>according to standard<br>ISO 7176-14:2008 and<br>software validation<br>requirement and there<br>are no new safety and<br>effectiveness concerns<br>due to the difference. | | Turning Radius | 600 mm | 900 mm | The minor difference in<br>the turning radius is<br>caused by different size<br>of wheelchair and may<br>cause a little bit<br>inconvenience when it<br>turns in a narrow space<br>while the minor<br>difference will not raise<br>any new safety and<br>effectiveness concerns | VI. Comparison of technological characteristics with the predicate device {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## VII. Summary of substantial equivalence discussion The power wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014. {10}------------------------------------------------ The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close, and frame materials all meet the Tensile Strength, Yield Load, and Elongation tests. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Turning radius and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2:2001, ISO 7176-10:2008. The flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10, while the predicate device is carried out according to the ISO 7176-16 test. Both of the two testing methods are recognized consensus standards for flammability resistance. Therefore, both devices are assured to be under the same safety level. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. #### VIII. Summary of non-clinical testing #### A Performance testing-bench The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. - . Risk Analysis developed in accordance with ISO 14971:2019. - . Software validation - ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability - ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs - . ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes - ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs - {11}------------------------------------------------ and scooters for determination of theoretical distance range - . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space - ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs - ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions - . ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength - ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs - ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs - ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies ● - . ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. - . ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods - ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling. - . ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method - . ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters - . ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures - ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs - . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014. - AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard - A Biocompatibility of patient-contacting material {12}------------------------------------------------ The biocompatibility of the subject device was determined via the declaration of identical tissue-contacting materials to the predicate device, which evaluated biocompatibility according to the ISO 10993-5: 2009 and ISO 10993-10:2010 standards. ## IX. Summary of clinical testing No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device. #### X. Conclusions The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K220747.