BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR

K020188 · Taiwan Armada Enterprise Co., Ltd. · IOR · Mar 8, 2002 · Physical Medicine

Device Facts

• Record ID: K020188
• Device Name: BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT 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, Pediatric

Intended Use

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

Device Story

Biotech A1000 Super Sport Wheelchair; mechanical mobility device for children restricted to sitting position. Device provides manual mobility; operated by user or caregiver. Used in clinical or home environments. Benefits include increased independence and mobility for pediatric patients.

Technological Characteristics

Mechanical wheelchair; manual operation; pediatric form factor.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 MAR

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: K020188

Trade/Device Name: Biotech A1000 Super Sport Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: January 12, 2002 Received: January 18, 2002

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications felerenced above and nave acterimined in marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to comments proc to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The I ou may, increrere, market the act include requirements for annual registration, listing of general controls provisions of vactice, 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 If your device is classified (600 a00 70) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our councements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I DTC 3 lossantes of our device complies with other requirements of the Act that I DA has made a decormination administered by other Federal agencies. You must of any I cacal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, and manufacturing practice requirements as set CITY art 807), ademig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Kevin Walls, RAC

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,

Mark H. 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 ):__ FBA KO20188 DEVICE NAME: BIOTECH A1000 SUPER SPORT WHEELCHAIR

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to children 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

( Per 21 CFR 801.109 )

for Mark N Millener
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number

Over - The - Counter - Use_ /

( Optional Format 1-2-96 )

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