The HEARTWAY Power Chair. P23 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 onboard battery charger.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (HEARTWAY Power Chair, P23) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or reader performance. This document focuses on demonstrating substantial equivalence to a previously marketed device rather than providing a performance study with acceptance criteria for algorithm-based or diagnostic devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because the document describes a wheelchair, not a diagnostic or AI-driven device that would typically have such performance metrics. The "Performance Testing" section lists EMC reports and compliance with standards for electrically powered wheelchairs, which are safety and electrical compatibility tests, not clinical performance metrics.

However, I can extract information related to the substantial equivalence comparison:

Substantial Equivalence Comparison Summary:

The HEARTWAY Power Chair, P23 is compared to the HEARTWAY Attendant-Controlled Power Chair, TCI (K071006) for substantial equivalence.

Key Similarities (used as evidence for substantial equivalence):

Intended Use: Both devices provide mobility to persons restricted to a seated position for medical purposes.
Mainframes: Both devices have folded mainframes, meet strength and fatigue tests using the same material aspects.
Physical Specifications: Same weight limit, cruising range, suspension of cross brace, size of rear wheels, footplates, armrest type, and warranty.
Upholstery: Back upholstery material is the same fabric and passed ignition resistance tests.
Electronic Systems: Electronic systems (controller, batteries, switches, switching power supplies) are from the same suppliers and are UL certificated, ensuring the same safety level.

Key Differences (considered minor for substantial equivalence):

Control Method: Predicate device is attendant-controlled; new device is designed for general user control. (This is the primary functional difference).
Physical Dimensions: Minor differences in overall dimension, wheelchair weight, size of front wheels and seat.
Performance Specifications: Minor differences in incline capabilities, ground clearance, and curb climbing ability (as specified in the User's Manual).

The FDA determined that the device is substantially equivalent to legally marketed predicate devices, subject to general controls.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a stylized floral design above the text "HEARTWAY". The floral design is composed of several rounded shapes arranged in a circular pattern, resembling petals or leaves. The text "HEARTWAY" is written in a bold, sans-serif font.

EARTWAY MEDICAL PRODUCTS CO.

MAR 2 2 2010

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.tw

Image /page/0/Picture/3 description: The image shows a logo for TÜV, a German organization that provides inspection and product certification services. The logo consists of the letters "TÜV" in a bold, sans-serif font, with a stylized crown-like symbol above the letters. The logo is surrounded by some blurry artifacts, possibly due to the image quality or compression.

January 27, 2010

510(k) SUMMARY "

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

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

Date summary prepared:

Device Name:

Proprietary Name: HEARTWAY Power Chair, P23 POWERED WHEELCHAIR Common or Usual Name: Classification Name: POWERED WHEELCHAIR, Class II, 21 CFR 890.3860

Indications for Use:

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

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3:1995 (Electrically powered wheelchairs, scooters, and their chargers requirements and test methods)

Legally marketed device for substantial equivalence comparison: HEARTWAY Attendant-Controlled Power Chair, TCI (K071006)

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Image /page/1/Picture/0 description: The image shows a logo with a stylized butterfly or flower design above the word "HEARTWA". The butterfly/flower is composed of several rounded shapes arranged in a circular pattern, all filled in with solid black. The word "HEARTWA" is in a bold, sans-serif font, also in black, and appears to be the beginning of a longer word or phrase.

HEARTWAY MEDICAL PRODUCTS CO. BOAD 25 TAKCHUNG INDUSTRIAL PARK TANCHUNG TAMAA (Sales) 23583232 (Rep) FAX : 886

Image /page/1/Picture/2 description: The image contains two logos. The first logo is a TUV logo, which is a certification mark. The second logo is an ISO-9001 certified logo, which is a quality management system standard. The ISO logo is contained within a rounded rectangle.

Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are folded, materials of the two devices all meet the strength and fatigue tests and they use the same material aspects. The same weight limit, cruising range, suspension of cross brace, size of rear wheels, footplates, armrest type, and the warranty are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.

The main different for the two devices are the feature of the predicate device is designed for attendant-controlled to drive, and the new device is designed for general used to drive. Thus, the differences between the two devices are very minor including overall dimension, wheelchair weight, size of front wheels and seat, incline capabilities, and the relevant spècifications for ground clearance and curb climbing ability in the User's Manual. Thus for the real life use, the two devices are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 abstract image of an eagle.

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

Heartway Medical Products Co., Ltd. % Dr. Ke-Min Jin ROC Chinese - European Ind. No. 58, Fu-Chuin Street Hsin Chu City, TW HSQ China (Taiwan) 30067

MAR 2 2 2010

Re: K100327

Trade/Device Name: HEARTWAY Power Chair, P23 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 27, 2010 Received: February 4, 2010

Dear Dr. Jin:

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. Ilsting 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

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Page 2 – Dr. Ke-Min Jin

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (K) Number ( If Known ): K

Device Name: HEARTWAY Power Chair, P23

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE

Concurrence of CDRH, Office of Device Evaluation (ODE)

MHILLIAM H. HODGES FOR M.MEELKERSON
(BY) John al. 68

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100327

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).