The HEARTWAY Power Wheelchair, P25 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an external battery charger.

AI/ML Overview

The HEARTWAY Power Wheelchair, P25 (K132856) is a powered wheelchair intended to provide mobility to persons restricted to a seated position. The device's performance was evaluated against a series of ISO 7176 standards related to wheelchairs and other relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Standard / Criteria	Acceptance Criteria (Implicit from Compliance)	Reported Device Performance (Implicit from Compliance)
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)	Compliance with Electromagnetics Compatibility requirements	Compliant (Reported as completed)
ISO 7176-1 (Static stability)	Compliance with static stability requirements	Compliant (Reported as completed)
ISO 7176-2 (Dynamic stability)	Compliance with dynamic stability requirements	Compliant (Reported as completed)
ISO 7176-3 (Brake effectiveness)	Compliance with brake effectiveness requirements	Compliant (Reported as completed)
ISO 7176-4 (Energy consumption/theoretical distance range)	Compliance with energy consumption requirements	Compliant (Reported as completed)
ISO 7176-5 (Overall dimensions, mass, maneuvering space)	Compliance with dimensional, mass, and maneuvering space requirements	Compliant (Reported as completed)
ISO 7176-6 (Max speed, acceleration, deceleration)	Compliance with speed, acceleration, and deceleration limits	Compliant (Reported as completed)
ISO 7176-7 (Seating dimensions)	Compliance with seating dimension definitions and measurement methods	Compliant (Reported as completed)
ISO 7176-8 (Static, impact, and fatigue strength)	Compliance with strength requirements	Compliant (Reported as completed)
ISO 7176-9 (Climatic tests)	Compliance with climatic test requirements	Compliant (Reported as completed)
ISO 7176-10 (Obstacle-climbing ability)	Compliance with obstacle-climbing ability requirements	Compliant (Reported as completed)
ISO 7176-11 (Test dummies)	Compliance with test dummy specifications	Compliant (Reported as completed)
ISO 7176-13 (Coefficient of friction of test surfaces)	Compliance with coefficient of friction standards	Compliant (Reported as completed)
ISO 7176-14 (Power and control system)	Compliance with power and control system requirements	Compliant (Reported as completed)
ISO 7176-15 (Information disclosure, documentation, labeling)	Compliance with information, documentation, and labeling requirements	Compliant (Reported as completed)
ISO 7176-16 (Resistance to ignition of upholstered parts)	Compliance with ignition resistance requirements	Compliant (Reported as completed)
ISO 7176-21 (EMC of powered wheelchairs and scooters)	Compliance with electromagnetic compatibility requirements	Compliant (Reported as completed)
UL Certification (for electronic systems)	Compliance with UL safety standards	Compliant (P&G VR2 controller, batteries, recharger, switches, power supplies are UL certified)
Maximum Weight Bearing Capacity	120 kgs / 265 lbs	120 kgs / 265 lbs (stated as a specification)
Incline Capability	Over 10 degrees (recommended not to operate on slopes over 10 degrees, implying capability for up to 10 degrees)	10 degrees (same as predicate device)
Turning Radius	650 mm / 25.6"	650 mm / 25.6" (stated as a specification)
Ground Clearance	80 mm / 3.2"	80 mm / 3.2" (stated as a specification)
Curb Climbing Ability	75 mm / 3.0"	75 mm / 3.0" (stated as a specification)

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for performance testing of the device itself (P25). It does mention various ISO and other standards that the device complies with, implying that testing was conducted according to the methodologies defined by these standards. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The nature of these tests (e.g., laboratory simulations, physical trials) is characteristic of prospective performance evaluations during product development and regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information (number and qualifications of experts) is not typically detailed for performance testing of a medical device like a powered wheelchair, as the ground truth is established by objective measurements and adherence to engineering standards. The compliance with ISO and other recognized standards serves as the basis for "ground truth" concerning the device's physical and electrical performance.

4. Adjudication Method for the Test Set:
Not applicable for this type of performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is involved. For this device, compliance is determined by objective measurements against established standard criteria.

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:
Not applicable. This is not an AI-assisted diagnostic or interpretive device, but rather a mobility device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, and its performance is evaluated through standardized physical and electrical tests.

7. The Type of Ground Truth Used:
The ground truth is established by adherence to internationally recognized engineering and safety standards (e.g., ISO 7176 series, CISPR, EN, IEC, ANSI/RESNA WC/Vol.2) and UL certifications. These standards define objective performance criteria and test methods for powered wheelchairs.

8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-driven device that requires a training set.

9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows a logo with a stylized floral design above the word "HEART-WAY" in bold, block letters. The floral design is composed of four petal-like shapes arranged in a circular pattern, set against a square background. A thin vertical line extends upwards from the left side of the word "HEART-WAY", terminating in a small circle.

HEARTWAY MEDICAL PRODUCTS CO

NO.6, ROAD 26, 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 salatumcharncomte !

ISO-9001
CERTIFICATED

510(k) SUMMARY " 66

K132856

Submitter's Name: HEARTWAY Medical Products Co., Ltd.

No.6, Road 25, Taichung Industrial Park, Taichung, 40850, Taiwan, ROC

Date summary prepared: Device Name:

July 15, 2014

Proprietary Name:	HEARTWAY Power Wheelchair, P25
Common or Usual Name:	POWERED WHEELCHAIR
Classification Name:	POWERED WHEELCHAIR, Class II,
	21 CFR 890.3860
Product Code:	ITI
Name of Contact Person:	Dr. Jen, Ke-Min
	Tel: +886-4-23580357 Fax: +886-3-5209783
	Email:ceirs.jen@msa.hinet.net

Indications for Use:

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

Description of the device:

The HEARTWAY Power Wheelchair, P25 is an indoor / outdoor power chair that is It has a base with four-wheeled with a seat, and armrests. battery operated. The movement of the power chair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an external battery charger.

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.

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Image /page/1/Picture/0 description: The image shows a logo with a stylized floral design above the word "HEART-WA". The floral design consists of four rounded petals arranged in a circular pattern, set against a square background. A thin vertical line extends upwards from the left side of the word "HEART-WA", terminating in a small circle.

HEARTWAY MEDICAL PRODUCTS CO.,L

NO.6, ROAD 26. 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

Image /page/1/Picture/3 description: The image shows a logo with the text "TUV CERT" in a stylized font. The logo is surrounded by a circular border. Below the logo, there is a rectangular box with rounded corners, but the text inside is not legible. The image appears to be a certification mark or quality assurance symbol.

ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes, 2003.

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, 1992.
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.

Device major components description:

The maximum weight bearing capacity of the device is 120 kgs / 265 lbs.

The feature of the body structure, the rear two wheels can always contact the surface, and the vehicle can operate on the rough surface. We provide the components and assembling drawing in the User's Manual. But the following surfaces are recommended not to operate on:

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Image /page/2/Picture/0 description: The image shows a logo with a stylized butterfly or flower design above the word "HEARTWA". The butterfly/flower is black and is set against a black square. The word "HEARTWA" is in a bold, sans-serif font. The image is black and white.

HEARTWAY MEDICAL PRODUCTS CO.

TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN 95 - 23583232 (Rep) FAX:886-4-23590786

Sand surface .
Wet or icy surface
Road maintenance hole metal cover
Too steep incline over 10 degrees.
. Turning Radius 650 mm / 25.6"
Ground clearance 80 mm / 3,2"
Curb climbing ability 75 mm / 3.0"

Compare to the legally marketed device for substantial equivalence: Predicate Device: HEARTWAY Power Chair, P23 (K100327)

Summary for substantial equivalence comparison:

The indications for use between the two devices are the same. Mainframes of two devices are folded and they use the same material. The mainframe materials of the two devices all meet the strength and fatigue tests. The incline capabilities. cross brace suspension, footplates, armrest type, and the warranty are all the same. The back upholstery material is also made of the same fabric and passes the ignition-resistance test in accordance with ISO 7176-16.

Specifically, the electronic systems for two devices are the same controller, i.e., P & G VR2, and are from the same suppliers. The electronic controller, batteries, recharger, and the competent switches and switching power supplies all pass the UL certification. Thus the same safety and effectiveness levels for the two devices are assured.

The main differences for the two devices are overall dimensions. Therefore, the weight limit, cruising range, maximum speed, wheelchair weight, the sizes of wheels and seat, and the relevant specifications for ground clearance and curb climbing ability are different. But two devices all meet the ISO 7176 series standards requirements. Thus for the real-life use instead of different dimensional specifications, the two devices are substantially equivalent.

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Image /page/3/Picture/0 description: The image shows a logo for HEART-WAY. The logo features a stylized heart shape with four lobes, resembling a flower or clover. The word "HEART-WAY" is printed in bold, sans-serif letters below the heart shape. The image appears to be a cropped section from a larger document or advertisement.

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 - : •

Image /page/3/Picture/3 description: The image contains two logos. The first logo is the "TUV CERT" logo, which is a certification mark. The second logo is the "ISO-9001 CERTIFICATED" logo, which indicates that the organization is certified to the ISO 9001 standard. The year 2005 and the Japanese word "本当時代" are also present in the image.

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E-mail : sales@heartway.com : w ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Comparison Table _

Similarities:

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
BRAND NAME	HEARTWAY
MANUFACTURER	HEARTWAY Medical Products Co., Ltd.
SERIES	Power Wheelchair System Series
MODEL NO	P23	P25
510K NO	K100327	K132856
INTENDED USE	The device is intended formedical purposes toprovide mobility to personsrestricted to a sittingposition.	Same
Frame	Folded	Same
Electronics	P & G, VR2controller	Same
Suspension	Cross brace	Same
Footplates	ABS	Same
Incline	10 degrees	Same
Back Upholstery	Fabric	Same
Armrest Types	Flip-backward	Same
Recharger	24VDC(UL 1310 certified)	Same
Wheel Lock	Push-to-Lock	Same
Warranty	3 years: Main frame1 years: Controller / gear motor /batteries w/o exhaustive andwear parts	Same
ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
Overall Dimension
Overall length	1100 mm / 43.3"	830 mm / 32.7"
Overall width	660 mm / 26.0"	650 mm / 25.6"
Overall height	1100 mm / 43.3"	1060 mm / 41.7"
Weight Limit	135 kgs / 300 lbs	120 kgs / 265 lbs
Maximum Speed	6.0 km/hr ( 3.8mile/h )	9.6 km/hr ( 6.0mile/h )
BatteriesQuantity	Two	Two
Type	34Ah 12VDC	50Ah 12VDC
Range per charge	26~30km / 18 miles	35km / 22 miles
Rear Wheels	10" x 3.3" solid x 2	14" x 3.0" solid x 2
Casters	6.0" x 2" solid x 2	10" x 3.3" solid x 2
Seat Size
Width	66 cm / 26.0"	48 cm / 18.9"
Length	85 cm / 33.5"	44 cm / 17.3"
Height	30 cm / 11.8"	53 cm / 20.9"
Turning Radius	550 mm / 21.7"	650 mm / 25.6"
Ground Clearance	75 mm / 3.0"	80 mm / 3.2"
Curb ClimbingAbility	60 mm / 2.4"	75 mm / 3.0"
Wheelchair Weight	w/i batteries 85kgs / 187 lbsw/o batteries 60kgs / 132 lbs	w/i batteries 125kgs / 276 lbsw/o batteries 75kgs / 165 lbs

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Image /page/4/Picture/0 description: The image shows a logo for HEART-WAY. The logo consists of a stylized flower or leaf design in black, positioned above the word "HEART-WAY" in bold, black letters. The flower design is abstract, with rounded shapes forming a petal-like structure.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:888-4-23580357 (Sales)·23583232 (Rep) FAX:886-4-23590786 Wab : www.heartway.com.tw

Image /page/4/Picture/3 description: The image contains a logo for "TUV CERT". The logo consists of the letters "TUV" stacked on top of the word "CERT", and the entire wordmark is surrounded by two concentric circles. The logo is black and white.

CERTERCATED

E-mail : sales@heartway.com.w

Differences:

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.

Public Health Service

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

July 15, 2014

HEARTWAY Medical Products Co., Ltd. c/o Dr. Jen. Ke-Min No. 6 Road 25, Taichung Industrial Park Taichung, 40850 Taiwan, ROC

Rc: K132856

Trade/Device Name: HEARTWAY Power Wheelchair. P25 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 5, 2014 Received: June 12, 2014

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. 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

Image /page/5/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized with three curved lines representing its wings and body.

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Page 2 - Dr. Jen, Ke-Min

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/ResourcesforYou/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 Aguel - 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132856

Device Name

HEARTWAY Power Wheelchair, P25

Indications for Use (Describe)

This device is intended for medical purposes to provide mobility to persons restricted 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

:15 -S Date: 2014.07.15

17:47:42 -04'00'

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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:

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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).