(168 days)
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.
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.
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.
The provided FDA 510(k) summary for the Power Wheelchair, W5521 (K231508) focuses on demonstrating "substantial equivalence" to a predicate device (Power Wheelchair, N5515B, K220747) through non-clinical testing. It does not involve AI/ML components or clinical effectiveness studies in the typical sense of a comparative effectiveness study with human readers for image-based diagnostics.
Therefore, many of the requested elements pertaining to AI/ML device performance (like acceptance criteria for accuracy, recall, F1-score, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable to this specific device submission.
The "acceptance criteria" in this context refer to compliance with various ISO and IEC standards for wheelchairs, which are physical and electrical performance benchmarks, not AI model metrics.
Here's a breakdown of the information provided in relation to your questions, noting where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are the successful compliance with the listed ISO and IEC standards. The "performance" is stated as meeting these standards.
| Acceptance Criteria (Relevant Standards) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7176-1:2014 (Static stability) | Complied with requirements |
| ISO 7176-2:2017 (Dynamic stability of electric wheelchairs) | Complied with requirements |
| ISO 7176-3:2012 (Effectiveness of brakes) | Complied with requirements |
| ISO 7176-4:2008 (Energy consumption for theoretical distance range) | Complied with requirements |
| ISO 7176-5:2008 (Dimensions, mass, maneuvering space) | Complied with requirements |
| ISO 7176-6:2018 (Max speed, acceleration, deceleration) | Complied with requirements |
| ISO 7176-7:1998 (Seating and wheel dimensions) | Complied with requirements |
| ISO 7176-8:2014 (Static, impact, fatigue strength) | Complied with requirements |
| ISO 7176-9:2009 (Climatic tests) | Complied with requirements |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Complied with requirements |
| ISO 7176-11:2012 (Test dummies) | Complied with requirements |
| ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Complied with requirements |
| ISO 7176-14:2008 (Power and control systems) | Complied with requirements; Software validated |
| ISO 7176-15:1996 (Information disclosure, documentation, labeling) | Complied with requirements |
| ISO 16840-10:2021 (Resistance to ignition of postural support devices) | Complied with requirements |
| ISO 7176-21:2009 (Electromagnetic compatibility) | Complied with requirements |
| ISO 7176-22:2014 (Set-up procedures) | Complied with requirements |
| ISO 7176-25:2013 (Batteries and chargers) | Complied with requirements |
| IEC 60601-1-2:2014 (Electromagnetic Compatibility Testing) | Complied with requirements |
| AIM 7351731 (Electromagnetic Immunity Test) | Complied with requirements |
| ISO 10993-5:2009 & ISO 10993-10:2010 (Biocompatibility) | Complied via identical materials to predicate |
2. Sample Size Used for the Test Set and Data Provenance
- This device is a physical product (power wheelchair), not an AI/ML diagnostic software. The "tests" are performance and safety evaluations against engineering standards, typically involving a limited number of physical units, not a large data set in the usual sense. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of clinical data sets (e.g., country of origin, retrospective/prospective). The tests are engineering bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. "Ground truth" in this context is defined by engineering standards (e.g., a specific static stability angle, braking distance, maximum speed). No human experts are establishing "ground truth" for a test set in the way a radiologist would for medical images. Compliance is measured instrumentally against predefined criteria in the standards.
4. Adjudication Method for the Test Set
- Not applicable. Since there are no human interpretations or "readings" to adjudicate, this concept does not apply.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a power wheelchair, not a diagnostic device involving human readers or AI assistance in interpretation. Thus, MRMC studies and effect sizes related to human reader improvement with AI are not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. There is no AI algorithm in the diagnostic sense that performs "standalone." The device itself is a standalone product. It has a control system with software, and the document states "Software validation" was performed, which refers to validating the functional correctness and safety of the embedded software controlling the wheelchair's operations as per ISO 7176-14:2008.
7. The Type of Ground Truth Used
- For physical performance and safety (e.g., stability, braking, speed, obstacle climbing, EMC): The "ground truth" is defined by the technical specifications and limits established in the various ISO and IEC performance standards (e.g., "Maximum safe operational incline degree: 6°", "Braking distance: ≤1 m").
- For material safety (biocompatibility): Ground truth is established by declaration of identical materials to a previously cleared predicate device, which had already demonstrated biocompatibility per ISO 10993 standards.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML model trained on a data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, this question is not relevant.
In summary, this 510(k) submission is for a conventional medical device (a power wheelchair) and relies on compliance with established international performance and safety standards, as well as substantial equivalence to a previously cleared predicate device. It does not involve the type of AI/ML performance evaluation studies that your questions are designed to address.
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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"
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(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
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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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)
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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
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.
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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/Conclusion |
|---|---|---|---|
| Manufacturer | Zhejiang InnuovoRehabilitation Devices Co.,Ltd. | Zhejiang InnuovoRehabilitation DevicesCo., Ltd. | / |
| Proprietary name,model | Power Wheelchair, W5521 | Power Wheelchair,N5515B | / |
| 510(k) number | K231508 | K220747 | / |
| Device classificationname | Class II | Class II | Same |
| Classificationregulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Similarities | |||
| Indication for use | The Power Wheelchair is amotor driven, indoor andoutdoor transportationvehicle with the intended useto provide mobility to adisabled or elderly personlimited to a seated position. | The Power Wheelchair isa motor driven, indoorand outdoortransportation vehiclewith the intended use toprovide mobility to adisabled or elderlyperson limited to a seatedposition. | Same |
| Intended user | disabled people with mobilitydifficulties and elderly people | disabled people withmobility difficulties andelderly people | Same |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 6, including two front wheelsand two rear wheels, twoanti-tip wheels | 6, including two frontwheels and two rearwheels, two anti-tipwheels | Same |
| Function of wheels | Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheelsto control the speed anddirectionAnti-tip wheels: preventingthe wheelchair from tippingturning over when driving onthe slope. Non-adjustable. | Front wheels: drivenwheels suitable forrotation, acceleration,retrogradeRear wheels: drivingwheels to control thespeed and directionAnti-tip wheels:preventing thewheelchair from tippingturning over when drivingon the slope.Non-adjustable. | Same |
| Movement controlmethod | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rearwheels | Direct drive on the rearwheels | Same |
| Brake system | Automaticelectromagneticbrake system | Automaticelectromagneticbrake system | Same |
| Battery charger | Off-board chargerInput: 100-240V, 50/60Hz,1.5A,Output: 24 Vdc, 2A; | Off-board chargerInput: 100-240V,50/60Hz, 1.5A,Output: 24 Vdc, 2A; | Same |
| back cushion | Polyester fabric | Polyester fabric | Same |
| seat cushion | rubber patch cloth andOxford fabric | rubber patch cloth andOxford fabric | Same |
| Armrest | Polyurethane (PU) | Polyurethane (PU) | Same |
| Max loading weight | 136kg (≈300 lbs) | 136kg (≈300 lbs) | Same |
| Maximum obstacleclimbing | 40 mm | 40 mm | Same |
| Differences | |||
| Main frame material | aluminum alloy | Carbon fiber material | Different material usedfor frame, that suchdifference 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.Different frame material caused different weight of the wheelchair. This difference will not raise any new safety and effectiveness concerns. |
| Overall Dimension (lengthwidthheight) | 1040mmX600mmX1020mm | 940mmX610mmX960mm | Minor difference on wheelchair dimension |
| Stowage Dimension (lengthwidthheight) | 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 standardISO 7176 series. | |||
| Braking distance | ≤1 m | ≤1.5 m | minor difference onbraking distance will notcause differentperformance. Shorterdistance for braking willbe more safety. |
| Battery | li-ion battery pack;rechargeable, 24 VDC 10Ah | li-ion battery pack;rechargeable, 24 VDC 12Ah | minor difference onbattery capacity will notcause differentperformance. Thisdifference will not raiseany new safety andeffectiveness concerns. |
| Maximum distanceof travel on the fullycharged battery | 10km | 15 km | Minor difference ontravel distance will notcause differentperformance. Thisdifference will not raiseany new safety andeffectiveness concerns |
| Motor | Brush DC motor; 24VDC;200W; 2pcs | Brushless DC motor;24VDC; 250W; 2pcs | minor difference onmotor power will notcause differentperformance. Both ofthe motors areevaluated according tostandard ISO7176-14:2008 and thereare no new safety andeffectiveness concernsraised due to thedifference. |
| Electronic controller | Micon M7086 controller | Micon M7084 controller | Similar controller isused, both the controlsystem, including thejoystick controller, theelectromagnetic brakesand the user interfaceare similar. The joystickcontrols the directions |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| and speed ofmovement, and whenthe joystick is released,the powered wheelchairwill slow down to stopand the brakes willautomaticallyre-engage. Thecontroller also providesthe battery statusdisplaying and abnormalcondition displaying.Both of the controlsystems are evaluatedaccording to standardISO 7176-14:2008 andsoftware validationrequirement and thereare no new safety andeffectiveness concernsdue to the difference. | |||
| Turning Radius | 600 mm | 900 mm | The minor difference inthe turning radius iscaused by different sizeof wheelchair and maycause a little bitinconvenience when itturns in a narrow spacewhile the minordifference will not raiseany new safety andeffectiveness concerns |
VI. Comparison of technological characteristics with the predicate device
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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.
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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 -
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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
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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.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).