The wheelchair (Model: DC01) 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.

Device Description

The device is Electric Wheelchair, model no. is DC01. An electric wheelchair is a four-wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The electric wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway.

The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, electromagnetic brake system, battery box, controller and battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back cushion.

The device is powered by Li-ion Battery pack (24V 6Ah, 144Wh) with 20 Km (12.5 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 patient 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 intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Anhui JBH Medical Apparatus Co., Ltd.'s Portable Folding Electric Wheelchair, Model DC01. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K113463, PL001 power wheelchair, SUZHOU KID MEDICAL APPLIANCE CO., LTD.).

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are based on compliance with various international standards for wheelchairs. The "device performance" column below indicates compliance with these standards, effectively stating that the device meets the functional and safety requirements outlined by these standards.

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
Static Stability (ISO 7176-1:2014)	Complied with the requirements.
Dynamic Stability of Electric Wheelchairs (ISO 7176-2:2017)	Complied with the requirements. Minor differences in maximum obstacle climbing and maximum speed do not impact safety/effectiveness as both meet ISO 7176-2:2017 requirements.
Effectiveness of Brakes (ISO 7176-3:2012)	Complied with the requirements. Shorter braking distance in the subject device compared to the predicate device, but all relevant tests performed according to ISO 7176-3, with no safety/performance affected. Brake system designed in the same way as predicate.
Energy Consumption & Theoretical Distance Range (ISO 7176-4:2008)	Complied with the requirements.
Dimensions, Mass, and Maneuvering Space (ISO 7176-5:2008)	Complied with the requirements.
Maximum Speed, Acceleration, Deceleration (ISO 7176-6:2018)	Complied with the requirements.
Seating and Wheel Dimensions (ISO 7176-7:1998)	Complied with the requirements.
Static, Impact, and Fatigue Strength (ISO 7176-8:2014)	Complied with the requirements.
Climatic Tests for Electric Wheelchairs (ISO 7176-9:2009)	Complied with the requirements.
Obstacle-Climbing Ability (ISO 7176-10:2008)	Complied with the requirements. Minor differences in maximum obstacle climbing and maximum speed do not impact safety/effectiveness as both meet ISO 7176-10:2008 requirements.
Test Dummies (ISO 7176-11:2012)	Complied with the requirements. (This standard defines test dummies used for other tests).
Coefficient of Friction of Test Surfaces (ISO 7176-13:1989)	Complied with the requirements.
Power and Control Systems (ISO 7176-14:2008)	Complied with the requirements. Design principles of controller and driving system are the same as predicate, and both meet ISO 7176-14:2008. Software validation was carried out.
Information Disclosure, Documentation, Labeling (ISO 7176-15:1996)	Complied with the requirements.
Resistance to Ignition of Upholstered Parts (ISO 7176-16:2012)	Complied with the requirements. (Implied, as cushion/back cushion are made of flame retardant material).
Electromagnetic Compatibility (ISO 7176-21:2009)	Complied with the requirements. Electromagnetic Compatibility Testing also performed in accordance with IEC 60601-1-2:2014.
Determination of User Performance (ISO 7176-22:2014)	Complied with the requirements.
Batteries and Chargers (ISO 7176-25:2013)	Complied with the requirements. As for battery differences, both batteries tested according to IEC 62133-2. Safety/performance not affected.
Secondary Cells and Batteries Safety (IEC 62133-2:2017)	Complied with the requirements.
Biocompatibility (ISO 10993-1:2018, -5:2009, -10:2010)	Evaluated according to ISO 10993-1. Biocompatibility tests (cytotoxicity, sensitization, irritation) performed on patient-contact materials (seat cushion, back cushion, armrest, frame, controller surface, joystick). Test results show all materials are bio-safe.
Risk Analysis (ISO 14971:2019)	Developed in accordance with the standard.
Software Evaluation	Software validation was carried out on both control systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench testing and compliance with international standards for manufactured goods. Therefore, the concept of "sample size" for a clinical test set or data provenance in the traditional sense (e.g., patient data) is not applicable here. The "test set" refers to the specific physical device (Model DC01) and its components that underwent various engineering and safety tests outlined by the ISO and IEC standards. The data provenance would be the results generated from these bench tests, conducted by the manufacturer or a certified testing facility, likely in China given the manufacturer's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a medical device (powered wheelchair), not an AI/diagnostic software. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation or diagnostic accuracy is not applicable. The "ground truth" for this device's performance is defined by its adherence to the technical specifications and safety requirements outlined in the referenced ISO and IEC standards. The expertise involved would be in engineering, materials science, and regulatory compliance, ensuring the tests are conducted correctly and the results are interpreted against the standard's pass/fail criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable to the type of device and testing performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results, where multiple human readers assess cases and discrepancies are resolved by a senior expert. For a physical device like an electric wheelchair, tests are objective measurements against defined performance thresholds in engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Absolutely no MRMC study was done. This device is a physical product (electric wheelchair), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to AI algorithm performance. As the device is an electric wheelchair, an "algorithm only" performance study is not applicable. The device's operation involves a human user in control via a joystick, and its performance is assessed against physical and electrical safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by compliance with international safety and performance standards for powered wheelchairs (e.g., ISO 7176 series, IEC 60601-1-2, IEC 62133-2) and biocompatibility standards (ISO 10993 series). These standards define objective, measurable criteria for a device to be considered safe and effective for its intended purpose.

8. The sample size for the training set

This concept is not applicable. A "training set" typically refers to data used to train a machine learning algorithm. This submission is for a physical medical device, not an AI/ML product.

9. How the ground truth for the training set was established

This concept is not applicable for the reasons stated above.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 6, 2022

Anhui JBH Medical Apparatus Co., Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1401. No.1500. Century Ave. Pudong New District, Shanghai 200122 China

Re: K212092

Trade/Device Name: Portable Folding Electric Wheelchair, Model DC01 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 5, 2022 Received: February 10, 2022

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 (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.

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

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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

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Indications for Use

510(k) Number (if known) K212092

Device Name

Portable Folding Electric Wheelchair (Model: DC01)

Indications for Use (Describe)

The wheelchair (Model: DC01) 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.

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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K212092 510(k) Summary

Name: Anhui JBH Medical Apparatus Co., Ltd

Address: No. 116 qicang Road, Mingguang City, Chuzhou, Anhui, China

Name of contact person: Yang Dandan

Tel: 0086-18936033123

Fax: 0086-550-8106688

Date prepared: 2021/06/30

Submission Correspondent:

Primary contact: Ms. Ivy Wang

Shanghai SUNGO Management Consulting Co., Ltd.

Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: +86-21-58817802

Email: haiyu.wang(@sungoglobal.com

Secondary contact: Mr. Raymond Luo

Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: +86-21-68828050

Email: fda.sungo@gmail.com

I. Device

Device trade name: Portable Folding Electric Wheelchair

Device model: DC01

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

II. Predicate device

K113463, PL001 power wheelchair, SUZHOU KID MEDICAL APPLIANCE CO., LTD. page 1 of 9

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III. Device description

IV. Indication for use

The wheelchair (Model: DC01) 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.

Attribute	Subject device	Predicate device	Discussion/Conclusion
Manufacturer	Anhui JBH MedicalApparatus Co., Ltd	SUZHOU KD MedicalAppliance Co. Ltd.	/
Proprietaryname, model	Electric Wheelchair, DC01	Power wheelchair, PL001	/
510(k) number	K212092	K113463	/
Deviceclassificationname	Class II	Class II	Same
Classification	21 CFR 890.3860	21 CFR 890.3860	Same
Attributeregulations	Subject device	Predicate device	Discussion/Conclusion
Product code	ITI	ITI	Same
Similarities
Intended user	disabled people andelderly people	disabled or elderly person	Same
Indication foruse	The wheelchair (Model:DC01) is a motor driven,indoor and outdoortransportation vehicle withthe intended use to providemobility to a disabled orelderly person limited to aseated position.	They are motor driven,indoor and outdoortransportation vehicle withthe intended use to providemobility to a disabled orelderly person limited to aseated position.	Same
Use condition	indoor and outdoor use	indoor and outdoor use	Same
Number ofwheels	4, including two frontwheels and two rearwheels	4, including two pivotingcasters and two rear drivewheels	Same
Function ofwheels	Front wheels: drivenwheels suitable forrotation, acceleration,retrogradeRear wheels: drivingwheels to control the speedand direction	Two pivoting casters:driven wheels suitable forrotation, acceleration,retrogradetwo rear drive wheels:driving wheels to controlthe speed and direction	Same
Movementcontrolmethod	By Joystick control	By Joystick control	Same
Drivingsystem	Direct drive on the rearwheels	Direct drive on the rearwheels	Same
Brake system	Smart Electromagneticbrake	Intelligent regenerativeElectromagnetic brake	Same
Electroniccontroller	Dual Drive Controller forBrushless Motor	Brushless dual-driverocker controller	Same
Motor	Brushless DC motor180W x 24 VDC x 2 pcs	Brushless DC motor; 24VDC; 180 W; 2 pcs	Same
Armrest	PU	PU	Same
Max speedforward	3.75 mph (6 km/h)	Up to 6 km/h (3.75 mph),variable	Same
Maximumdistance oftravel on thefully chargedbattery	20 km	20 km	Same
TurningRadius	800 mm	31.5" (800 mm)	Same
Differences
Frame designand material	The frame of thewheelchair is type capableof front and rear close. Themain part of the frame canbe folded for saving spaceand convenient storage andtransportation. The mainframe is made of carbonfiber material.	The frame of thewheelchair is type ofaluminum frame with frontand rear folding structure;Up-and-down turnablehandrail, front and rearadjustable armrest. Themain frame is made ofaluminum alloy material.	both of the wheelchaircan be folded in theway of front and rearfolding type.
Minimumbrakingdistance from	Forward: 0.5 m	Forward: 1.5 m	shorter brakingdistance in the subjectdevice than the
Attribute	Subject device	Predicate device	Discussion/Conclusion
maximum speed			predicate device, all relevant tests are performed according to standard ISO 7176-3, no safety and performance will be affected.
Battery	Lithium-ion, 24V6Ah, 6Ah x 24 VDC	Li-ion, Rechargeable; 24 VDC 20Ah	Same rated voltage, as for difference on power capacity, both batteries are tested according to standard IEC 62133-2, no differences of batteries between both devices will affect the safety and performance of the subject device.
Battery charger	Off-board chargerInput: 100-240Vac, 50/60Hz, 1.5 A;output: DC 24V, 2A,	Off-board, Automatic TypeInput: 110-220 V / 50-60 Hz,Output: 24 Vdc, 2A	More wide range of input voltage in the device which will not cause new safety and effectiveness concerns raised.
seat cushion/back cushion	linen cloth filled with PU foam	PU foam covered by nylon fabric cloth	Different surface material in contact with the driver, the biocompatibility evaluation is performed on both devices, such difference will not affect the safety and performance of the subject device
Maximum safe operational incline degree	8 °	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 according to standard ISO 7176 series.
Max loading weight	120 kg (264 lbs)	114 kg (251 lbs)	Minor difference on loading weight will not cause different performance as all performance tests are performed according to standard ISO 7176 series
Front wheel size/type	7" x 1.75" /PU Solid tire	6"x 2"/PU Solid tire	different size of driven wheel will not affect safety and performance of the subject device as all related stability tests are performed
Attribute	Subject device	Predicate device	Discussion/Conclusion
Rearwheelsize/type	8"x1.95" /PU solid tires	8" x 2.4"/PU Solid tire	according to standardISO 7176 series.different size of drivingwheel will not affectsafety and performanceof the subject device asall related stability testsare performedaccording to standardISO 7176 series.
Maximumobstacleclimbing	20 mm	1.2" (30 mm)	less distance in theobstacle climbing willnot impact the safetyand effectiveness of thesubject device.

V Comparison of technological characteristics with the predicate device

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Summary of substantial equivalence discussion VI.

The DC01 electric wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, 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 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.

The intended uses for both devices are totally same. Mainframes of two devices are folded by way of front and rear close, although the locking structure for both devices are different from each other, the folding principle is the same. As for different frame materials used and minor difference on safe operational incline degree for both devices, considering all safety and performance tests are carried out on the subject device with favorable result, such difference will not affect the safety and performance of the subject device. 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. Maximum obstacle climbing and maximum speed 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 7176-2:2017, ISO 7176-10:2008. The biocompatibility of the subject device is evaluated according to standard ISO 10993-1 and meet the requirements accordingly.

All seat cushion/back cushion and armrest are made of flame retardant material for both devices.

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Therefore, the subject device is 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 device do not raise new issues of safety or effectiveness.

VII. Summary of non-clinical testing (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 evaluation
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 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 .

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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 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014. ●
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications

VIII. Biocompatibility of patient-contacting material

Biocompatibility of patient-contacting material are evaluated in accordance with ISO 10993-1: 2018. All parts of the wheelchair surface in contact with user skin are patient contact parts for the electric wheelchair. The biocompatibility tests are carried out on patient-contact materials, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010). The test results show all materials used are bio-safe. Below is the summary table:

Component name	Material	Direct contact/indirect contact	Contactbody	Contactduration	Evaluation tests
Seat cushion(surface)	linen cloth	Direct	intact skinsurface	<24 Limited	CytotoxicitySensitizationIrritation
	Back cushion(surface)
Armrest		PU (polyurethane)
Frame	carbon fiber	Direct	intact skinsurface	<24 Limited	CytotoxicitySensitizationIrritation

controller surface	plastic part	Direct	intact skinsurface	<24 Limited	CytotoxicitySensitization
Joystick	plastic part	Direct	intact skinsurface	<24 Limited	Irritation

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.

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X. Conclusions

The differences between DC01 electric wheelchair and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device electric wheelchair DC01 is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 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).