WU'S 4-WHEELED NEO SCOOTER, WT-M4JR

K032489 · Wu'S Tech Co., Ltd. · INI · Sep 24, 2003 · Physical Medicine

Device Facts

• Record ID: K032489
• Device Name: WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Sep 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

The WU's 4-Wheeled Neo Scooter (WT-M4Jr) is a motorized vehicle designed to provide mobility to individuals with restricted ability to walk. The device functions as a personal transport aid, allowing users to navigate environments while seated. It is intended for use by patients requiring mobility support. The device is operated by the user. It provides mechanical mobility, assisting users in daily activities and improving independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized four-wheeled vehicle; 21 CFR 890.3800; Class II; Product Code INI.

Indications for Use

Indicated for persons restricted to a seated position who require 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

SEP 2 4 2003

Wu's Tech Co., Ltd. Dr. Ke-Min Jen c/o Roc Chinese-European Industrial Research Society No. 58. Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300

Re: K032489

Trade/Device Name: WU's 4-Wheeled Neo Scooter, WT-M4Jr Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: August 7, 2003 Received: August 12, 2003

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 - Mr. 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Milbern

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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510 (K) NUMBER ( IF KNOWN ): ): TBA DEVICE NAME: WU'S 4-WHEELED NEO SCOOTER, WT-M4Jr

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 )

OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over - The - Counter - Use

( Per 21 CFR 801.109 )

ptional Format 1-2-96 )

for Mark A. Millman
(Division Sign-On)

cral, Restorative

510(k) Number K03 2487