BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR

K020472 · Taiwan Armada Enterprise Co., Ltd. · IOR · Mar 8, 2002 · Physical Medicine

Device Facts

• Record ID: K020472
• Device Name: BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
• Applicant: Taiwan Armada Enterprise Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Biotech B900 Super Light Wheelchair; mechanical mobility device for individuals restricted to sitting position. Provides manual transport; operated by user or caregiver. Used in home, clinical, or community settings. Simple mechanical construction; no electronic or software components. Benefits patient by restoring mobility and independence.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Mechanical wheelchair; manual operation. No energy source, software, or electronic components. Materials and dimensions typical of standard mechanical wheelchairs.

Indications for Use

Indicated for persons 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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MAR 8 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K020472

Trade/Device Name: Biotech B900 Super Light Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 6, 2002 Received: February 12, 2002

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the based in the 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 I ou may, atteresy missions 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 r hat 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 or any I vith 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,

b. Mark N. Millers

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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210 (K) NUMBER ( IF KNOW ): _ TBA __ KOLO472 DEVICE NAME: BIOTECH B900 SUPER LIGHT 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 )

| Prescription Use | OR Over-The-Counter-Use <span style="text-decoration: overline;">✓</span> |
|-----------------------|---------------------------------------------------------------------------|
| (Per 21 CFR 801.109 ) | ( Optional Format 1-2-96 ) |

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

| 510(k) Number | K020472 |
|---------------|---------|
|---------------|---------|