WU'S 3-WHEELED NEO SCOOTER, WT-T3B

K023168 · Wu'S Tech Co., Ltd. · INI · Jan 24, 2003 · Physical Medicine

Device Facts

• Record ID: K023168
• Device Name: WU'S 3-WHEELED NEO SCOOTER, WT-T3B
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Jan 24, 2003
• 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-T3B) is a motorized three-wheeled vehicle designed to provide mobility to individuals restricted to a seated position. The device functions as a personal mobility aid, allowing users to navigate environments while seated. It is intended for use by individuals with mobility limitations. The device is operated by the user.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; class II; product code INI; regulation 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2003

Wu's Tech Company, LTD C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, R.O.C.

Re: K023168

Trade/Device Name: Wu's 3-Sheeled Neo Scooter, WT-T3B Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: December 13, 2002 Received: December 20, 2002

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 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.

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), 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 yours,

Mark A. Milliman

Celia 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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510 (K) NUMBER ( IF KNOWN ):__ TBA WU'S 3-WHEELED NEO SCOOTER, WT-T3B 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

OR

Over - The -- Counter - Use_

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

Mark N Mulkern
Division Size 283

Ensterative

510(k) Number K023168