The HEARTWAY Electrically Powered Wheelchair, Model P19 is battery powered and configured with four solid wheels, a seat, a controller to control the driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, and a set of anti-tippers. Main frame carries a width foldable seat system and a set of rear anti-tipper to prevent a patient from tipping their wheelchairs backward. P19 maximum weight capacity is 250 lbs (113kg). Maximum speed is 3.75 mph (6 km per hour). The device can be folded for transport and is provided with an external battery charger.

AI/ML Overview

This document is a 510(k) premarket notification for the HEARTWAY Electrically Powered Wheelchair, Model P19. It focuses on demonstrating substantial equivalence to a predicate device, not on proving general acceptance criteria for a novel device through a standalone study. Therefore, several aspects of your request (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, how ground truth was established) are not directly applicable or available in this type of submission.

However, I can extract the acceptance criteria (standards applied) and the reported device performance in relation to those standards from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Applied)	Reported Device Performance
EMC Testing:	Completed.
- ANSI / RESNA WC/Vol.2: 2009
- CISPR 11: 2004+A2:2006
- EN61000-4-2: 2008
- IEC61000-4-3: 2006
- IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
- ISO 7176-21: Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009
Mechanical & Performance Testing (ISO 7176 Series):	Completed.
- ISO 7176-1: Determination of static stability, 1999	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-2: Determination of dynamic stability of electric wheelchairs, 2001 (Dynamic incline angle)	Passed. "Two devices all pass the ISO 7176-2 standard, the dynamic stabilities of two devices are all assured."
- ISO 7176-3: Determination of effectiveness of brakes, 2012	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-5: Determination of overall dimensions, mass and manoeuvring space, 2008	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-7: Determination of seating dimensions Definitions and measuring method, 1998	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-8: Static, impact and fatigue strength for manual wheelchairs, 1998	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-9: Climatic tests for electric wheelchairs, 2009	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-11: Test dummies, 2012	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-13: Determination of coefficient of friction of test surfaces, 1989	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-14: Power and control system for electric wheelchairs, 2008	Passed. (Implied by conclusion of substantial equivalence)
- ISO 7176-15: Requirements for information disclosure, documentation and labelling, 1996	Passed. (Implied by conclusion of substantial equivalence)
Ignition Resistance:	Completed.
- ISO 7176-16: Requirements and test methods for resistance to ignition of upholstered parts, 2012	"Back upholstery material...passed the resistance ignition test."
Material Biocompatibility:	Completed.
- ISO 10993-1:2009	"Same" as predicate (which references these standards).
- ISO 10993-5:2009
- ISO 10993-10:2010(E)
Charger Safety Certification:	Completed.
- UL-certified (UL E201162)	"Two chargers are UL-certified and there are no safety and effectiveness hazards."
- UL 1310 (Predicate device charger)	(Predicate's standard, not explicitly stated for subject, but subject's charger is UL-certified)

2. Sample size used for the test set and the data provenance

Sample Size: This document does not specify a "test set" in the context of a statistical study with a specific number of units. The testing refers to conformity with established international and national standards (ISO, ANSI/RESNA, CISPR, IEC) for medical devices like powered wheelchairs. Typically, such testing involves a limited number of physical units (prototypes or production samples) of the device being evaluated, not a large "test set" of data samples. The exact number of units tested is not provided.
Data Provenance: The tests were performed according to international standards for wheelchair performance and safety. The location where these tests were conducted is not explicitly stated, but the manufacturer is based in Taiwan, R.O.C., so it is likely undertaken by a certified lab either in Taiwan or abroad. The nature of these tests is prospective (evaluation of the device itself) rather than retrospective data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of submission. "Ground truth" in this context is established by the well-defined and quantitative metrics and methodologies specified within the cited international engineering and safety standards (e.g., ISO 7176 series). Expertise is embedded in the standards themselves and the accreditation of the testing facility, rather than a panel of clinical experts establishing ground truth for individual cases.

4. Adjudication method for the test set

Not applicable. Performance against engineering and safety standards is typically determined by objective measurements and pass/fail criteria defined within the standards, not through adjudication by multiple experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The HEARTWAY Electrically Powered Wheelchair is a physical medical device for mobility, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

Not applicable. The device is a physical powered wheelchair, not an algorithm. Its performance is evaluated through physical and electrical testing against established standards, not as a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is defined by adherence to the objective, measurable parameters and criteria set forth in the international engineering, safety, and electromagnetic compatibility standards (e.g., ISO 7176 series, ANSI/RESNA WC/Vol.2, CISPR, IEC for EMC, ISO 10993 for biocompatibility, UL for chargers). These standards represent an industry consensus on acceptable performance and safety for such devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no 'training set' in the context of algorithm development.

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

Not applicable, as there is no training set mentioned in this context.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. Above the profiles are three curved lines that resemble wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

HEARTWAY Medical Products Co., Ltd. c/o Dr. Jen, Ke-Min Official Correspondent No.6, Road 25, Taichung Industrial Park Taichung City 40850 Taiwan, R.O.C.

Re: K142731

Trade/Device Name: HEARTWAY Electrically Powered Wheelchair, Model P19 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 20, 2015 Received: January 28, 2015

Dear Dr. Jen, Ke-Min:

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. Isting 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Felipe Aquel -S

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

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Indications for Use

510(k) Number (if known) K142731

Device Name

HEARTWAY Electrically Powered Wheelchair, Model P19

Indications for Use (Describe)

The device is intended for medical purposes to provide mobility to persons restricted to a sitting 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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Image /page/3/Picture/0 description: The image shows a logo with a butterfly-like design in purple against a blue square. To the left of the square, there's a thin yellow line with a small yellow circle at the top. Below the line and square, the word "HEARTWA" is printed in bold, black letters. The logo appears to be for an organization or company with a focus on heart-related matters.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408
TEL:886-4-23580357 (Sales). 23583232 (Rep) FAX:886-4-23590786
Web: www.heartway.com.tw
E-mail sales@heartway.com by

Submitter's Name:	HEARTWAY Medical Products Co., Ltd.No.6, Road 25, Taichung Industrial Park, Taichung, 40850,Taiwan, ROC
Date summary prepared:	February 5, 2015
Device Name Proprietary Name:	HEARTWAY Electrically Powered Wheelchair, Model P19
Common or Usual Name:	POWERED WHEELCHAIR
Classification Name:	Class II, 21 CFR 890.3860
Product Code:	ITI
Company contact:	Mr. Henry Wu (henry@heartway.com.tw)

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Description of the device:

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Image /page/4/Picture/0 description: The image shows a logo with a purple butterfly-like shape against a blue square. A thin yellow line extends from the top left corner of the square to a small yellow circle above the word "HEARTWA" in bold black letters. The logo appears to be for an organization or company with a name starting with "HEARTWA".

EARTWAY MEDICAL PRODU

E-mail : sales@heartway.com.tw

CERT

ISO-9001
CERTIFICATED

Performance Testing:

1. EMC Report ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).
1. ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999.
1. ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs, 2001.
1. ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012.
1. ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008.
1. ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space, 2008.
1. ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001.
1. ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998.
1. ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs. 1998.
1. ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
1. ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008.
1. ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012.
1. ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989.
1. ISO 7176-14 Power and control system for electric wheelchairs, 2008.
1. ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996.
1. ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
1. ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.

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Image /page/5/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the word is a blue square with a purple butterfly-like shape inside. To the left of the square is a yellow line with a circle at the top.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

TÜV-FRITZ

CERTIFICATED

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw al

E-mail : sales@heartway.com.tw

COMPARISON TABLE

ITEMS	PREDICATE DEVICE	SUBJECTDEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate device
Brand name	HEARTWAY		Same brand
Manufacturer	HEARTWAY MedicalProducts Co., Ltd.		Samemanufacturer
Series	Lightweight SystemSeries	ElectricallyPoweredWheelchair	Different series
Model	P15	P19	Different model
510K number	K071005	K142731	Differentsubmissions
	Similarity
Intended use	The device is intendedfor medical purposesto provide mobility topersons restricted to asitting position.	Same	Same
FrameTypematerial	FoldedAluminum alloy	Same	Same
Weight limit	115 kgs / 250 lbs	Same	Same
Footplates	ABS	Same	Same
Backupholstery	Fabric	Same	Same
Armrest types	Flip-backward	Same	Same
Wheel Lock	Push-to-Lock	Same	Same
Suspension	Cross brace	Same	Same
Patientcontactingmaterial	Seat PVC materialHand grip PVC materialSeat belt PVC material	Same	Same
Biocompatibility	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010(E)	Same	Same
Warranty	3 years: Main frame1 years: Controller /gear motor / batteriesw/o exhaustive andwear parts	Same	Same warranty
Differences
Maximumspeed	9.6km/h( 6 mph)	6 km/h(3.75mph)	Smaller speed
Overalldimension
Overall length	940 mm / 37"	850 mm / 33"	Smaller
Overall width	610 mm / 24"	520 mm / 20"	dimensions
Overall height	980 mm / 38.5"	830 mm / 32"
Electronics	P & G, VR2controller	Dynamic LiNXLE Systemcontroller	Differentcontrollers
Batteries
Quantity	Two	Two	Same
Type	22Ah 12VDC	12Ah 12VDC	Smaller capacity
Range percharge	20km / 12.5 miles	15km / 9.32 miles	Smaller range
Rear wheels
Quantities	2	2
Sizes/type	12 1/2" * 2 1/4"(PU solid tire)	8" * 2"(PU solid tire)	Smaller tires

Casters	7" * 1.75"(2 PU solid tires)	7" * 1.6"(2 PU solid tires)	Smaller castors
Seat size
Width	75 cm / 29.5"	41 cm / 16.1"	Smaller seat
Depth	57 cm / 22.4"	33 cm / 12.9"	Sizes
Height	37.5 cm / 14.8"	35 cm / 13.7"
Curb climbing	60 mm	40 mm	Smaller curb
Dynamic incline angle	10 degrees	6 degrees	Smaller angle
Ground clearance	120 mm	40 mm	Smaller clearanc
Turning radius	480 mm	735 mm	Larger radius
Motor
Quantity	2	2	Same
Type	24V, 200W	24V, 150W	Smaller power
Wheelchair Weight	w/ batteries 43kgs /95 lbsw/o batteries 28.5kgs /63 lbs	w/ batteries36.5kgs /80.5lbsw/o batteries28kgs / 61.7 lbs	14.5 lbswheelchairweightdifferenceand smallerbattery weight
Charger	24VDC(UL 1310 )	24VDC(UL E201162)	DifferentUL-certifiedchargers

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Image /page/6/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters. Above the word is a blue square with a purple butterfly-like design inside. To the left of the logo is a thin, yellow line with a small circle at the top.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw al 60

Image /page/6/Picture/3 description: The image shows two logos. The top logo is the "TUV CERT" logo, with the letters "TUV" stacked on top of the word "CERT". The bottom logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is stacked in three lines.

E-mail : sales@heartway.com.tw

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Image /page/7/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. Below the square, the word "HEARTWAY" is written in bold, black letters. A thin yellow line extends from the left side of the word upwards, ending in a small yellow circle.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw al 60

Image /page/7/Picture/3 description: The image shows an email address. The email address is sales@heartway.com.tw. The text "E-mail :" is written before the email address.

Image /page/7/Picture/7 description: The image shows two logos. The first logo is the "TÜV CERT" logo, with the word "TÜV" in a stylized font above the word "CERT". The second logo is a rounded rectangle containing the text "ISO-9001 CERTIFICATED".

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Image /page/8/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. To the left of the square, there is a yellow circle connected to a vertical yellow line. Below the square and line, the word "HEARTWA" is written in bold, black letters.

HEARTWAY MEDICAL PRODUCTS O

COMPARISON DISCUSSION

The intended uses for the two devices are the same. Mainframes of two devices are folded, and frame materials all meet the Strength, Yield Load, and Elongation tests. Weight load, footplates, armrest type, suspension, static incline angle, patient-contacting materials (biocompatibility) and the warranty are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test. Thus the same safety level for the two devices is assured.

Basically, the overall dimensions, seat dimensions, rear wheels sizes and front castors sizes of the subject device is smaller than those of the predicate device. Thus, the wheelchair weight for the smaller size of the same aluminum alloy material should be smaller. In order to drive the heavier wheelchair with a faster speed, the motor powers and the batteries capacities of the predicate device must be larger than those of the subject device, based on the work-energy theorem. Since the motor power and battery capacity of the subject device are smaller than those of the predicate device, the cruise range is smaller. These differences are not related to the safety and effectiveness aspects.

Owing to the smaller height and smaller wheels and castors, the ground clearance and curb climbing of the subject device are smaller than those of the predicate device. As for the larger turning radius for the subject device, it is due to the different software processing speeds among two different electronic controllers. Two different electronic controllers are certified to function safely and effectively. Thus different radius and different electronic controllers do not raise any safety and effectiveness aspects. They are substantially equivalent.

Dynamic incline angle 6 degrees for the subject device is smaller than 10 degrees for the predicate device. This is due to the wheelchair weight of the predicate device is 14.5 lbs heavier than that of the subject device and this comes mainly from the battery weight difference. The battery boxes are all located at bottom of the wheelchairs and it lowers the height of center of gravity of the predicate device. These facts all increase the incline angle of the predicate device. But two devices all pass the ISO 7176-2 standard, the dynamic stabilities of two devices are all assured. There are no safety and effectiveness concerns. They are substantially equivalent with respect to this difference.

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Image /page/9/Picture/0 description: The image shows the logo and contact information for Heartway Medical Products Co., LTD. The logo features a stylized purple butterfly-like design next to the company name in bold black letters. Below the name is the company's address, phone and fax numbers, website, and email address. Certifications from TUV and ISO-9001 are also displayed.

The battery chargers are different but are the same 24 VDC type. Two chargers are UL-certified and there are no safety and effectiveness hazards. The difference does not raise any safety and effectiveness concerns.

Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC 2, Section 21 for the EMC test. They function safely and effectively. There are no safety and effectiveness aspects concerned. Thus, the two devices are substantially equivalent.

CONCLUSIONS

The subject device, HEARTWAY Electrically Powered Wheelchair, Model P19, is as safe and effective as, and functions in a manner equivalent to the K071005 predicate device, HEARTWAY Lightweight System Series, P15. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the 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).