BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR

K020284 · Taiwan Armada Enterprise Co., Ltd. · IOR · Feb 8, 2002 · Physical Medicine

Device Facts

• Record ID: K020284
• Device Name: BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
• Applicant: Taiwan Armada Enterprise Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Feb 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

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

Device Story

Biotech A2000 Super Motive Wheelchair is a mechanical mobility device designed for individuals restricted to a sitting position. It functions as a standard mechanical wheelchair to provide transport and mobility. Operated by the user or an attendant, it is intended for use in clinical or home environments. The device provides physical mobility support, enabling users to navigate their surroundings. It does not incorporate electronic or motorized components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation; no electronic components or software; Class I device.

Indications for Use

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

Regulatory Classification

Identification

A mechanical wheelchair is a manually 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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 0 8 2002

Taiwan Armada Enterprise Co., Ltd. c/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research No. 58, Fu-Chiun Street Hsin-Chu City Taiwan, ROC

Re: K020284

Trade/Device Name: Biotech A2000 Super Motive Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: January 16, 2002 Received: January 28, 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 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 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,

R. Mark N. Milliman

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 KNOW): TBA K020284

DEVICE NAME: BIOTECH A2000 SUPER MOTIVE WHEELCHAIR

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to person restricted to a sitting 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 )

( Optional Format 1-2-96 )

Mark N Millkenan

sion of C neral, Restorative and Neurolog cal Devices

510(k) Numbe: K030384