WHILL Model M

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 12, 2016 Whill, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313 Re: K153543 Trade/Device Name: Whill Model M Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 28, 2016 Received: January 29, 2016 Dear Mark Job: 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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Michael J. Hoffmann -A for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K153543 Device Name WHILL Model M Indications for Use (Describe) The intended use of the Model M powered wheelchair is to provide outdoor 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) X Prescription Use (Part 21 CFR 801 Subpart D) | 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}------------------------------------------------ ### 5 510(k) Summary | Submitter's Name: | WHILL, Inc. | |--------------------------|-------------------------------------------| | Address: | 285 Old County Rd, Suite 6, San Carlos CA | | Contact Person: | Terese Bogucki | | Title: | Regulatory Consultant | | Telephone Number: | 650-488-7799 | | Fax Number: | 650-227-2264 | | Email: | terri@decusbiomedical.com | | Date Summary Prepared: | August 24, 2015 | | Device Proprietary Name: | WHILL Model M Powered Wheelchair | | Model Number: | Model M | | Common Name: | Powered Wheelchair | | Regulation Number: | 21 CFR 890.3860 | | Product Code: | ITI | | Device Class: | II | # Predicate Device | Trade Device Name: | F3 Corpus | |------------------------|------------------------------------------------------------| | Manufacturer: | Permobil AB | | Address: | Per Uddens Vag 20 Timra, SE 86123 Vasternorrland<br>Sweden | | Regulation Number: | 21 CFR 890.3860 | | Regulation Name: | Wheelchair, Powered | | Regulatory Class: | Class II | | Product Code: | ITI | | 510(k) Number: | 143180 | | 510(k) Clearance Date: | March 27, 2015 | {4}------------------------------------------------ #### 5.1 Description of the Device The WHILL Model M is an indoor/outdoor battery-operated 4 wheel drive powered wheelchair. It is powered by two 12 VDC 50Ah batteries and controlled by the R-net 120 amp motor controller. As with all commerciallyavailable powered wheelchairs, the user sits in the wheelchair seat and uses controls positioned on the arms to turn the chair on, control the speed, and direct the movement. The directional controller can be mounted on the left or right arm. When the user activates the directional controller the brakes are released and the motors rotate to move the device in the desired direction. When the user releases the directional controller the device is brought to a controlled stop. The chair frame is a welded nut and steel construction and includes two rear wheels with drive units (motor, gear and brake) connected by belts to the front all directional wheels. Adjustments can be made to the two arm supports, foot support, and seat height and depth to position the user correctly in the device. The device supports a maximum weight of 220 lb, and has an approximate driving range of 12 miles. The device can be operated on carpet, tile, wood, vinyl, concrete, blacktop, dirt, gravel, grass, and wet (<1" standing water) surfaces. #### 5.2 Indications for Use The intended use of the Model M powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. #### 5.3 Summary of Technological Characteristics Comparison Table 5-1 shows the similarities and differences between the two products. The key difference is that the subject device has the front all-directional wheel and the device controls on two arms instead of one. While these characteristics are different, the testing demonstrates that they do not raise new questions of safety or effectiveness. | Item | Predicate | Subject Device | |---------------|-------------|----------------| | General | | | | Manufacturer | Permobil AB | WHILL, Inc. | | Model | F3 Corpus | Model M | | 510(k) Number | K143180 | unknown | Table 5-1 Summary of Technological Characteristics Comparison {5}------------------------------------------------ | Item | Predicate | Subject Device | | | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Intended Use | To provide indoor and outdoor<br>mobility to persons restricted<br>to a sitting position that are<br>capable of operating a powered<br>wheelchair. | Same | | | | Indications for<br>Use | The intended use of the F3<br>powered wheelchair is to<br>provide indoor and outdoor<br>mobility to persons limited to a<br>seating position that are<br>capable of operating a powered<br>wheelchair. | The intended use of the Model<br>M powered wheelchair is to<br>provide outdoor and indoor<br>mobility to persons limited to<br>a seated position that are<br>capable of operating a<br>powered wheelchair. | | | | Rx/OTC<br>Designation | Rx or OTC | Rx | | | | Physical Characteristics | | | | | | Device Width | 24" | 23.6" | | | | Device Length | Drive base only:<br>40" with anti-tippers<br>36" without anti-tippers | 37"- 42" (depending on foot<br>plate setting) | | | | Weight (including<br>batteries) | 386 lb with Group 34 batteries<br>405 1b with Group 24 batteries | 240 lb | | | | Device<br>Construction | Steel | Welded nut and steel | | | | Batteries (2) | 12VDC 60Ah (Group M34) or<br>12VDC 73Ah (Group M24) | 12V 50Ah | | | | Operating Characteristics | | | | | | Maximum Weight<br>Capacity | 300 lb (136 kg) | 220lb (100kg) | | | | Maximum Speed | 6 mph<br>5 mph (without anti-tippers) | 5.5 mph | | | | Turning Radius | 26.5" | 28" | | | | Obstacle Climbing<br>Height | 3" | 3" | | | | Drive System | Front wheel drive | 4 Wheel Drive | | | | Dynamic Stability<br>(incline) | 6 degrees | 10 degrees | | | | Item | Predicate | Subject Device | | | | Driving Range<br>(full battery<br>charge) | 13 miles | 12 miles | | | | Battery Charging<br>Time | 8 hours | ~8 hours to 80% | | | | Design Features | | | | | | Power Controller | R-net 120 amp controller | R-net 120 amp controller | | | | Speed Settings | 5 (maximum) | 3 | | | | Front Wheel Type | Pneumatic or foam-filled | All directional wheel | | | | Rear Wheel Type | Solid polyurethane | Pneumatic or solid | | | | Anti-tip Wheels | Front anti-tip wheels (optional) | Rear anti-tip wheels | | | | Pressure relief<br>handles | None | Yes | | | | Seat slide | No | Yes | | | | Tail lamps (2) | Reflectors<br>Lights (optional) | Red LED lights (always on) | | | | Chair Tilt/<br>Recline/ Leg Lift/<br>Seat Elevator | Yes | No | | | | Tie Downs | Yes | Yes (optional) | | | | Non-Clinical Performance Testing | | | | | | Wheel<br>Performance<br>Testing | Detailed performance testing<br>conducted to ISO 7176<br>standard | Detailed performance testing<br>conducted to RESNA WC-1,<br>WC-2 and WC-4 standards | | | | Flammability | Padded parts: EN 1021-1, EN<br>1021-2 and ISO 7176-16<br>Plastic parts: UL94 | Upholstered parts: ISO 8191-<br>1 and ISO 8191-2 and covers:<br>ISO 7176-16<br>Plastic parts: UL94 | | | {6}------------------------------------------------ #### Performance Data 5.4 In addition to design verification and validation testing WHILL conducted performance testing to demonstrate the subject device is in compliance with the following test standards: {7}------------------------------------------------ - ANSI/RESNA WC-1:2009 Section 1: Determination of Static ● Stability - ANSI/RESNA WC-2:2009 Section 2: Determination of Dynamic ● Stability - ANSI/RESNA WC-2:2009 Section 3: Determination of Effectiveness . of Brakes - ANSI/RESNA WC-2:2009 Section 4: Determination of Static . Stability Determination of Dynamic Stability Determination of Effectiveness of Brakes Energy Consumption for Determination of Theoretical Distance - ANSI/RESNA WC-1:2009 Section 5: Maneuvering Space ● Determination of Dimensions, Mass and Maneuvering Space - ANSI/RESNA WC-2:2009 Section 6: Determination of Maximum . Speed, Acceleration and Deceleration - ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of . Seating and Wheel Dimensions - ANSI/RESNA WC-1:2009 Section 8: Requirements and Test . Methods for Static, Impact and Fatigue Strengths - ANSI/RESNA WC-2:2009 Section 9: Climatic Tests ● - ANSI/RESNA WC-2:2009 Section 10: Determination of Obstacle ● Climbing - . ANSI/RESNA WC-1:2009 Section 11: Test Dummies - ANSI/RESNA WC-1:2009 Section 13: Determination Of Coefficient . Of Friction Of Test Surfaces - ANSI/RESNA WC-2:2009 Section 14: Power And Control Systems . For Electrically Powered Wheelchairs - Requirements And Test Methods - ANSI/RESNA WC-1:2009 Section 15: Requirements for Information . Disclosure, Documentation and Labeling - ANSI/RESNA WC-1:2009 Section 16: Resistance to ignition of . upholstered parts - Requirements and test methods (tests to ISO 8191-1 and ISO 8191-2) - ANSI/RESNA WC-4:2012 Section 19: Wheelchairs used as seats in . motor vehicles - ANSI/RESNA WC-2:2009 Section 21: Requirements and Test . Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters {8}------------------------------------------------ - ASTM D4169, Standard Practice for Performance Testing of ● Shipping Containers and Systems - ISO 7176-16: 2012 Wheelchairs -- Part 16: Resistance to ignition of ● postural support devices - . ISO 8191-1: 1987 Furniture -- Assessment of the ignitability of upholstered furniture -- Part 1: Ignition source: smouldering cigarette - ISO 8191-2: 1988 Furniture -- Assessment of ignitability of . upholstered furniture -- Part 2: Ignition source: match-flame equivalent - . UL 94 Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances - ISO 10993-1 Biological evaluation of medical devices -- Part 1: . Evaluation and testing within a risk management process - . ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity - . ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization - ISO 7176-14: 2008 Wheelchairs -- Part 14: Power and control . systems for electrically powered wheelchairs and scooters --Requirements and test methods (for R-Net Power Module) Based upon the results of this testing, it was determined the Model M performance was substantially equivalent to the predicate device. #### ર. ર Substantial Equivalence Conclusion The July 28, 2014 FDA Guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]'' was used to determine substantial equivalence. The analysis shows that the Intended Use and Indications for Use, principles of operation, and conditions of use are identical, and that differences in technical characteristics do not raise different questions of safety and effectiveness. There are technological differences between the subject and predicate device however, the results of performance testing demonstrate that these differences do not raise any new questions of safety or effectiveness compared to other similar powered wheelchairs currently on the market. Therefore one can conclude that the Model M is substantially equivalent to the predicate Permobil F3 Corpus device.