WU'S 3-WHEELED NEO SCOOTER, WT-M3

K014119 · Wu'S Tech Co., Ltd. · INI · Jul 25, 2002 · Physical Medicine

Device Facts

• Record ID: K014119
• Device Name: WU'S 3-WHEELED NEO SCOOTER, WT-M3
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Jul 25, 2002
• 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

Wu's 3-Wheeled Neo Scooter (WT-M3) is a motorized three-wheeled vehicle; provides mobility for individuals restricted to a seated position. Operated by the user; intended for personal transport. Device functions as a mobility aid; mechanical propulsion system. No complex software or algorithmic processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; class II device. Mechanical propulsion; standard mobility scooter form factor. No software, connectivity, or electronic sensing/actuation described.

Indications for Use

Indicated for persons restricted to a seated position who require a motorized three-wheeled vehicle for mobility.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2002

Wu's Tech Company, LTD. Ke-Min Jen, Ph.D. c/o Roc Chinese-European Industrial Research Soc. No. 58. Fu-Chiun Street Nsin-Chu City, China (Taiwan)

Re: K014119

Trade Name: Wu's 3-Wheeled Neo Scooter, WT-M3 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 4, 2002 Received: July 10, 2002

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Mark N. Mulkerson

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) FAX: [phone] TEL: [phone] Email: [e-mail] Homepage: www.wustecli.com.tw

## B.1 INTENDED USE

The intended uses for the subject device and the predicate device are the same and it is

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

le Mark N. Milleson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K014119 510(k) Number -