The HEARTWAY Electrically Powered Wheelchair, Model P27 is battery powered and configured with 2 PU solid front castors and 2 pneumatic rear drive wheels, a width adjustable seat, a controller to control the lighting function and driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, a seat cushion, a pair of skirts, a set of anti-tippers.

P27 powered wheelchair is rear-wheel driven and operated by two pneumatic rear wheels as the drive wheels, two solid front wheels as the front casters and uses upper joystick to control the driving direction, driving speed, and lighting function. Main frame carries a width adjustable seat system and a set of anti-tipper to prevent a patient from tipping their wheelchairs backward. Main frame is equipped with the front & rear independent suspensions to enhance the stability. A width-adjustable seat system carries a set of back rest system, a seat cushion, a pair of arm-rest, a pair of foot-rest, and a pair of skirts to provide seat posture positioning functions. P27 power wheelchair maximum weight capacity is 265 lbs (120kg). Maximum speed is 3.75 mph (6 kph). The device can be disassembled for transport and is provided with an external battery charger.

AI/ML Overview

This document describes a 510(k) premarket notification for the HEARTWAY Electrically Powered Wheelchair P27. The information provided focuses on demonstrating substantial equivalence to a predicate device (HEARTWAY Power Tilt Seating System Power Chair, P16RT) rather than presenting a study to prove a device meets specific acceptance criteria for diagnostic performance or treatment efficacy.

Therefore, many of the requested categories for acceptance criteria and study details (such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information) are not applicable to this type of regulatory submission. The "acceptance criteria" here are essentially the performance standards met to ensure safety and effectiveness in comparison to the predicate device.

Here's the breakdown of the available information:

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

The "acceptance criteria" in this context are the international standards (ISO 7176 series and ANSI/RESNA WC 2, Section 21 for EMC) that the device must pass to demonstrate safety and effectiveness. The reported device performance is that the subject device completed these performance tests. The document doesn't provide specific numerical results or thresholds for each test, but rather states that the device "function[s] safely and effectively" after completing them.

Acceptance Criteria (Standards Met)	Reported Device Performance
EMC Report ANSI/RESNA WC/Vol.2: 2009 (Section 21), CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001	Completed performance tests
ISO 7176-1: Determination of static stability, 1999	Completed performance tests
ISO 7176-2: Determination of dynamic stability of electric wheelchairs, 2001	Completed performance tests
ISO 7176-3: Determination of effectiveness of brakes, 2012	Completed performance tests
ISO 7176-4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008	Completed performance tests
ISO 7176-5: Determination of overall dimensions, mass and maneuvering space, 2008	Completed performance tests
ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001	Completed performance tests
ISO 7176-7: Determination of seating dimensions Definitions and measuring method, 1998	Completed performance tests
ISO 7176-8: Static, impact and fatigue strength for manual wheelchairs, 1998	Completed performance tests
ISO 7176-9: Climatic tests for electric wheelchairs, 2009	Completed performance tests
ISO 7176-10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008	Completed performance tests
ISO 7176-11: Test dummies, 2012	Completed performance tests
ISO 7176-13: Determination of coefficient of friction of test surfaces, 1989	Completed performance tests
ISO 7176-14: Power and control system for electric wheelchairs, 2008	Completed performance tests
ISO 7176-15: Requirements for information disclosure, documentation and labelling, 1996	Completed performance tests
ISO 7176-16: Requirements and test methods for resistance to ignition of upholstered parts, 2012	Completed performance tests
ISO 7176-21: Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009	Completed performance tests
Biocompatibility (ISO 10993-1, ISO 10993-5)	States "Same biocompatibility" as predicate, implying adherence.

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

Sample size: Not specified. This type of submission generally involves testing a single or a small number of devices against the listed standards. It is not a clinical study with a patient test set.
Data provenance: The document indicates the manufacturer is HEARTWAY Medical Products Co., Ltd. located in Taichung City, Taiwan. The testing was conducted against international standards (ISO, ANSI/RESNA).

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)

Not applicable. This is a performance testing submission against engineering and safety standards, not a clinical study requiring expert ground truth for diagnostic accuracy.

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

Not applicable. No clinical adjudication process is described. The tests are defined by the referenced 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

Not applicable. This is not an AI/software device and no MRMC study was performed.

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

Not applicable. This is a physical medical device (powered wheelchair), not an algorithm or AI.

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

Not applicable. The "ground truth" for this device's performance is adherence to the specified international safety and performance standards (ISO 7176 series and ANSI/RESNA WC 2, Section 21).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. 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

June 12, 2015

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

Re: K142783

Trade/Device Name: HEARTWAY Electrically Powered Wheelchair P27 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 12, 2015 Received: May 20, 2015

Dear 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 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.

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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

Carlos L. Peña, PhD, MS for

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) K142783

Device Name

HEARTWAY Electrically Powered Wheelchair P27

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 stylized butterfly design. The butterfly is purple and is set against a blue square. Below the butterfly is the word "HEARTWA" in black, with only part of the word visible. There is also a yellow circle with a line extending down to the word.

EARTWAY MEDICA

Image /page/3/Picture/2 description: The image contains two logos on a white background. The top logo is the "TUV CERT" logo, which is a blue circular design with the letters "TUV" in a bold, sans-serif font at the top and the word "CERT" in a smaller font below it. The bottom logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is in a simple, sans-serif font, and the rectangle has a thin, blue border.

510(k) SUMMARY

Submitter's Name:	HEARTWAY Medical Products Co., Ltd.
	No.6, Road 25, Taichung Industrial Park, Taichung, 40850,
	Taiwan, ROC
	TEL: 886-4-23580357 / 886-4-23583232
	FAX: 886-4-23590786
Date summary prepared:	March 20, 2015
Device Name
Proprietary Name:	HEARTWAY Electrically Powered Wheelchair, Model P27
Common or Usual Name:	POWERED WHEELCHAIR
Classification Name:	Powered Wheelchair, Class II,
	21 CFR 890.3860
Product Code:	ITI
Company contact:	Mr. Yang, T. H. (yhead0722@hotmail.com)
Official Correspondent:	Dr. Jen, Ke-min (ceirs.jen@msa.hinet.net)
Predicate device	K070489

Heartway Power Tilt Seating System Power Chair, P16RT

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 butterfly-like design in purple against a blue square. A yellow line extends from the left side of the square, ending in a small circle. Below the square, the word "HEARTWAY" is printed in bold, black letters. The logo appears to be for an organization or company named Heartway.

HEARTWAY MEDICAL PRODUCTS C 886-4-23580357 (Sales) - 23583232 (Rep) FAX : 886-4-23

Image /page/4/Picture/2 description: The image contains two logos. The first logo is the "TUV CERT" logo, with the word "TUV" in blue and the word "CERT" in white inside of a blue circle. The second logo is a blue rounded rectangle with the text "ISO-9001 CERTIFICATED" inside.

Performance Testing:

1. EMC Report ANSI / RESNA WC/Vol.2: 2009 (Section 21), 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.

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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/6/Picture/0 description: The image shows a logo with a purple butterfly-like design against a blue square background. To the left of the butterfly is a thin yellow line with a circle at the top. Below the butterfly and line is the word "HEARTWA" in bold, black letters.

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 പ

E-mail : sales@heartway.com.tw

Image /page/6/Picture/4 description: The image contains two logos. The top logo is for "TUV CERT" and features the letters "TUV" stacked on top of the word "CERT" inside of a circular design. The bottom logo is for "ISO-9001 CERTIFICATED" and features the text inside of a rounded rectangle.

COMPARISON TABLE

ITEMS	PREDICATEDEVICE	SUBJECTDEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate device
Brand name	HEARTWAY	HEARTWAY	Same brand
Manufacturer	HEARTWAY MedicalProducts Co., Ltd.		Same manufacture
Series	Power Tilt SeatingSystem power chair	Electrically PoweredWheelchair	Different design
Model	P16RT	P27	Different models
510K number	K070489	K142783	Differentsubmissions
Similarities
Intended use	The device isintended for medicalpurposes to providemobility to personsrestricted to a sittingposition.	The device isintended formedical purposesto provide mobilityto personsrestricted to asitting position.	Same intendeduse
FrameTypeMaterial	FoldedCarbon steel alloy	FoldedCarbon steel alloy	Same material
Footplates	ABS	ABS	Same material
Backupholstery	Fabric	Fabric	Same material
Armresttypes	Flip-backward	Flip-backward	Same type
Wheel Lock	Push-to-Lock	Push-to-Lock	Same type
Suspension	Cross brace	Cross brace	Same type
EARTWAY
Seat tiltingfunction	Yes	Yes	Same function
Patientcontactingmaterial	Seat PVC materialHand grip PVC materialSafety belt PVC material	Seat PVC materialHand grip PVCmaterialSafety belt PVCmaterial	Same material
Electroniccontroller	PG VR2 70 Amp	PG VR2 70 Amp	Same controller
Anti-tipper	Yes	Yes	Same function
Biocompatibility	ISO 10993-1ISO 10993-5	ISO 10993-1ISO 10993-5	Samebiocompatibility
Warranty	3 years: Main frame1 years: Controller /gear motor / batteriesw/o exhaustive andwear parts	3 years: Main frame1 years: Controller /gear motor /batteries w/oexhaustive and wearparts	Same warranty
		Differences
Maximumspeed	9.6km/h( 6 mph)	6 km/h(3.75 mph)	Smaller speed
Maximumuser weightcapacities	500 lbs / 225 kg	265 lbs/120 kgs	Smaller weight
OveralldimensionOverall length	1150 mm / 45"	1030 mm / 40.5"	Smaller Length
Overall width	660 mm / 26"	870-1420 mm/34.2"-55.9"	Larger width
Overall height	1170 mm / 46"	1250 mm / 49.2"	Larger height
BatteriesQuantityType	Two50Ah 12VDC	TwoSame	SameSame type
Range percharge	35km / 21.8 miles	32km / 20 miles	Smaller range

Rear wheels
Quantities	2	2	Smaller rear tires
Sizes/type	14.0" *3"x 2	12.4"x2.16"x2
	(PU solid tire)	(Pneumatic tire)
Casters	9.5" *3" x 2	7.48"x1.77"x2	Smaller castors
	(PU solid tire)	(PU solid tire)
Seat size
Width	66 cm / 25.9"	46 cm / 18"	Smaller seat width
Depth	87 cm / 34.2"	47 cm / 18.5"	& depth
Height	41 cm / 16.1"	49-60cm /	Larger seat
		19.3"-23.6"	height
Backrestrecliningfunction	No	Yes	Smaller inclineangle
Curbclimbing	65 mm/2.5"	50 mm/1.96"	Smaller curb
Dynamicincline angle	12 degrees	6 degrees	Smaller inclineangle
Groundclearance	80 mm/3.15"	50 mm/1.96"	Smaller clearance
Turningradius	610mm/24"	730 mm/28.7"	Larger turningradius
MotorQuantityType	224V, 500W	224V, 200W	SameSmaller power
Wheelchair	w/ batteries	w/ batteries	53 lbs frame
Weight	114kg / 251 lbs	90 kgs / 198 lbs	difference
	w/o batteries	w/o batteries
	84kgs /185 lbs	60 kgs / 132 lbs
Charger	24VDC	24VDC	Different
	(UL 1310 )	(UL E201162)	UL -certifiedchargers

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Image /page/7/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a purple butterfly-like shape against a blue square. The word HEARTWAY is written in bold, black letters below the square.

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 പ 60

Image /page/7/Picture/3 description: The image contains two logos. The first logo is the "TÜV CERT" logo, which is a blue circle with the letters "TÜV" in the center. The second logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. Both logos appear to be certification marks.

E-mail : sales@heartway.com.tw

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Image /page/8/Picture/0 description: The image shows a logo with a purple butterfly-like design on a blue square. To the left of the square is a yellow line with a circle at the top. Below the square is the word "HEARTWAY" in black, block letters. The background is white.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

TÜV-FREE

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

Image /page/8/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email address is preceded by the text "E-mail :". The email address is likely for sales inquiries related to the company Heartway. The domain name suggests that the company is located in Taiwan.

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Image /page/9/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. The word "HEARTWA" is written in black letters below the square. A yellow line with a circle at the top is on the left side of the image.

EARTWAY MEDICAL PRODUCTS O

COMPARISON DISCUSSION

For the maximum user weight capacity, wheelchair total weights, cruise range per charging and maximum speed, the subject device are smaller than the predicate device. The facts show the subject device is designed to perform in a lighter weight way than the predicate device. In order to function in a lighter weight design, rear wheels sizes and front castors sizes of the subject device can be smaller than those of the predicate device. To drive a lighter wheelchair with a slower maximum speed, the motor powers of the subject device can be smaller than those of the predicate device, based on the work-energy theorem. Since the motor powers and the maximum speed of the subject device are smaller than those of the predicate device, the cruise range is smaller according to the definition of work. These differences are only related to the designing aspects and not related to the safety and effectiveness aspects.

Owing to the 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 larger overall width of the subject device. But the subject device passes the ISO 7176 series standards, the static and dynamic stabilities are all assured. Thus different radius and different widths do not raise any safety and effectiveness aspects. They are substantially equivalent.

The overall height and seat height of the subject device are larger than those of the predicate device. The subject device performs in a lighter weight design and has a backrest reclining function and a less maximum user weight capacity, the center of gravity of the subject device is higher than that of the predicate device. The fact results in smaller incline angle of the subject device 6 degrees, compared with 12 degrees of the predicate device. After all, two devices all pass the ISO 7176-2 standard; the dynamic stabilities of two devices are all assured. And this 6 degrees limitation is shown in the P27 user's manual for safety operation. There are no safety and effectiveness concerns. They are substantially equivalent with respect to these differences.

The battery chargers are different model 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 aspects concerned.

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Image /page/10/Picture/0 description: The image is a business card for HEARTWAY MEDICAL PRODUCTS CO.,LTD. The card includes the company's logo, address, phone number (886-4-23580357), fax number (886-4-23590786), website (www.heartway.com.tw), and email address (sales@heartway.com.tw). The card also includes the TÜV CERT and ISO-9001 CERTIFICATED logos.

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 P27, is as safe and effective as, and functions in a manner equivalent to the K070489 predicate device, HEARTWAY Power Tilt Seating System power chair P16RT. 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).