HEARTWAY POWER MOBILITY SCOOTER, S8

K092155 · Heartway Medical Products Co., Ltd. · INI · Sep 21, 2009 · Physical Medicine

Device Facts

• Record ID: K092155
• Device Name: HEARTWAY POWER MOBILITY SCOOTER, S8
• Applicant: Heartway Medical Products Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

HEARTWAY S8 is a battery-operated, 4-wheeled indoor/outdoor electric mobility scooter. Rider operates device via hand controls on steering column. Features include seat, armrests, front basket, and onboard battery charger; device is disassemblable for transport. Electronic systems, including controller, batteries, and recharger, are UL-certified. Device provides mobility for individuals restricted to seated position. Safety and performance verified via EMC and electrical safety testing per ANSI/RESNA and IEC standards.

Clinical Evidence

Bench testing only. Performance verified via EMC and electrical safety testing per ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995.

Technological Characteristics

4-wheeled electric scooter; battery-operated. Components (controller, batteries, recharger) are UL-certified. Upholstery fabric passed resistance ignition testing. Connectivity: None. Sterilization: N/A. Software: None.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• HEARTWAY Power Mobility Scooter, PT7 (K073044)

Submission Summary (Full Text)

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## HEARTWAY MEDICAL PRODUCTS CO

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 40
TEL:[phone] (Sales)-23583232 (Rep) FAX:[phone]
Web: www.heartway.com.tw

il : [e-mail]

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ISO-9001
CERTIFICATED

K6921SS

#### દ દ 510(k) SUMMARY "

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

No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC

Date summary prepared:

Device Name:

July 5, 2009

Proprietary Name: Common or Usual Name: Classification Name:

HEARTWAY Power Mobility Scooter, S8 POWERED SCOOTER MOTORIZED 4-WHEELED VEHICLE, Class II, 21 CFR 890.3800 INI

Indications for Use:

Product Code:

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

Description of the device:

The HEARTWAY Power Mobility Scooter, S8 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter 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.

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 Power Mobility Scooter, PT7 (K073044)

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### HEARTWAY MEDICAL PRODUCTS CO .. LTD.

10.6. ROAD 25. TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 -4-23580357 (Sales)- 23583232 (Ren) FAX · 886-4-23590788

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#### Summary for substantial equivalence comparison;

According to the above table that the intended use between the two devices is the same. Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects. Moreover, the maximum speed, the suspension of cross brace, footplates, armrest type, and even the overall dimensions for the two devices are similar. 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, recharger, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.

Owing to the predicate device is three wheels scooter and the new device is four wheels scooter. Thus the main differences for the two devices are including weight capabilities, maximum slope, weights, cruising range, and the warranty. The safety levels of the two devices are the same and the differences of the overall weight and outer appearance are not safety aspect. They are substantially equivalent.

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SEP 2 1 2009 Heartway Medical Products Co., LTD % Chinese-European Industrial Research Society Dr. Ke-Min Jen No., 58, Fu-Chiun Street

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

Re: K092155

Hsin-Chu City China (Taiwan) 408

> Trade/Device Name: HEARTWAY Power Mobility Scooter, S8 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 5, 2009 Received: July 16, 2009

#### Dear Dr. Jen:

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 iddictions 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, Or ug, 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 misbaranding and adulteration.

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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#### Page 2 - Dr. Ke-Min Jen

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/CDRH/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/cdrl/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark McMillan

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 Mobility Scooter, S8

Indications for Use:

.

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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