WU'S 4-WHEELED NEO SCOOTER, WT-L4

K013763 · Wu'S Tech Co., Ltd. · INI · Jul 30, 2002 · Physical Medicine

Device Facts

• Record ID: K013763
• Device Name: WU'S 4-WHEELED NEO SCOOTER, WT-L4
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

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

Device Story

Wu's 4-Wheeled Neo Scooter (WT-L4) is a motorized mobility vehicle; provides transport for individuals with restricted mobility; operated by user via manual controls; intended for use in indoor/outdoor environments; facilitates independent movement for patients unable to walk; mechanical design focuses on stability and seated support.

Clinical Evidence

No clinical data provided; device evaluated via 510(k) regulatory pathway for mobility scooters.

Technological Characteristics

Motorized 4-wheeled vehicle; mobility aid; mechanical propulsion; class II device per 21 CFR 890.3800.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K013763

Trade Name: Wu's 4-Wheeled Neo Scooter, WT-L4 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 10, 2002 Received: July 16, 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.

JUL 3 0 2002

Image /page/0/Picture/11 description: The image shows a partial view of the Department of Health & Human Services USA seal. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines representing hair or movement. The image is in black and white.

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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 vour 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 yours.

Sincerely yours,

Mark N. Millers

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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Page

## 510 (K) NUMBER ( IF KNOWN ): _ TBA

WU'S 4-WHEELED NEO SCOOTER, WT-L4 DEVICE NAME:

## INDICATIONS FOR USE:

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

## ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use _

Over - The - Counter - Use_

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

for Mark n Milhuan
(Division Sign-Off)
Division of General, Restorative

OR

neral. Restorative and Neurological Devic

510(k) Number -

F1