SCOOTER MARS SERIES, MODEL TL-588

K022698 · Teh Lin Prosthetic & Orthopaedic, Inc. · INI · Dec 2, 2002 · Physical Medicine

Device Facts

• Record ID: K022698
• Device Name: SCOOTER MARS SERIES, MODEL TL-588
• Applicant: Teh Lin Prosthetic & Orthopaedic, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Dec 2, 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

Scooter Mars Series, Model TL-588 is a motorized three-wheeled vehicle designed to provide mobility for individuals restricted to a seated position. The device functions as a personal mobility aid, allowing users to navigate environments independently. It is intended for over-the-counter use. The device operates via an electric motor system to provide propulsion. It is used by patients with mobility limitations to improve their ability to move within their surroundings.

Technological Characteristics

Motorized three-wheeled vehicle; electric motor propulsion; Class II device; product code INI.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

DEC 0 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teh Lin Prosthetic & Orthopaedic, Inc. Dr. Ke-Min Jen c/o Roc Chinese European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan

Re: K022698 -

Trade/Device Name: Scooter Mars Series, Model TL-588 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: November 6, 2002 Received: November 12, 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

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Page 2 – Dr. Ke-Min Jen

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. 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 (301)-594-4639. 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,

Miriam C. Provost

Celia M. Witten, Ph.D., MD 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 ___________________________________________________________________________________________________________________________________________

DE VICE NAME: ___ SCOOTER MARS SERIES, TL-588

## 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_ -- Y

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

Miriam C. Provost

K022698