BIOTECH B990K VIVI WHEELCHAIR

K014198 · Taiwan Armada Enterprise Co., Ltd. · IOR · Feb 1, 2002 · Physical Medicine

Device Facts

• Record ID: K014198
• Device Name: BIOTECH B990K VIVI WHEELCHAIR
• Applicant: Taiwan Armada Enterprise Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

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

Device Story

Biotech B990K ViVi Wheelchair; mechanical mobility device for children restricted to sitting position. Provides manual transport; intended for use in clinical or home environments. Operated by patient or caregiver. Simple mechanical construction; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation. No energy source, connectivity, or software. Materials and construction consistent with standard mechanical wheelchair design.

Indications for Use

Indicated for children 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 01 2002

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

Re: K014198

Trade/Device Name: Biotech B990K ViVi Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: December 15, 2001 Received: December 21, 2001

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,

Sincerely, yours,

L. Mark A. Milken

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_KOTATAR BIOTECH B990K ViVi WHEELCHAIR DEVICE NAME:

INDICATIONS FOR USE:

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

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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 )

. Mula N. Mullan
Division Sign Off

Ceneral Restorative and Neure gical Devices

510(k) Number K014198.