TEH LIN POWERED WHEELCHAIR, MODEL MDG-201

K022696 · Teh Lin Prosthetic & Orthopaedic, Inc. · ITI · Feb 7, 2003 · Physical Medicine

Device Facts

• Record ID: K022696
• Device Name: TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
• Applicant: Teh Lin Prosthetic & Orthopaedic, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Feb 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Lin Powered Wheelchair, Model MDG-201, is a motorized mobility device designed for individuals unable to ambulate independently. It provides powered transport for users restricted to a sitting position. The device is intended for use in various environments to facilitate personal mobility. It functions as a standard powered wheelchair, allowing the user to control movement via an integrated interface. The device benefits the patient by restoring or enhancing independent mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered wheelchair; Class II; Product Code ITI. Operates via electric motor and battery power. Form factor is a standard wheelchair chassis with seating support.

Indications for Use

Indicated for persons restricted to a sitting position requiring mobility assistance.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.

FEB 0 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Lin Prosthetic & Orthopaedic, Inc. Ke-Min Jen, Ph.D. c/o ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin Chu City, China (Taiwan) 300

Re: K022696

Trade/Device Name: The Lin Powered Wheelchair, Model MDG-201 Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 26, 2002 Received: December 2, 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]. 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 N. Mikkelsen

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

Ericlosure

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510 (K) NUMBER ( IF KNOW ): _ TBA TEH LIN POWERED WHEELCHAIR MDG-201 DEVICE NAME:

INDICATIONS FOR USE:

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

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

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use ✓ OR

( Per 21 CFR 801.109 )

Division Sign Off

f General. Restorative and Neurological Devices

510(k) Number --

Over - The - Counter - Use____________________________________________________________________________________________________________________________________________________

( Optional Format 1-2-96 )