BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR

K011701 · Taiwan Armada Enterprise Co., Ltd. · IOR · Jun 22, 2001 · Physical Medicine

Device Facts

• Record ID: K011701
• Device Name: BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
• Applicant: Taiwan Armada Enterprise Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 22, 2001
• 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 persons restricted to a sitting position.

Device Story

Biotech Manual Wheelchair C650 Series Tour Light is a manually operated mobility device. Designed for individuals restricted to a sitting position to provide independent or assisted mobility. Operated by the user or a caregiver in various environments. Device provides physical support and transport for the patient; no electronic or automated components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual wheelchair; mechanical construction; no energy source; no software; no electronic connectivity.

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)

{0}------------------------------------------------

Public Health Service

## JUN 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K011701

Trade Name: Biotech Manual Wheelchair C650 Series Tour Light Wheelchair Regulation Number: 890.3850 Regulatory Class: I Product Code: IOR Dated: May 24, 2001 Received: June 1, 2001

## Dear Dr. Jen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Fecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

{1}------------------------------------------------

## Page 2 - Dr. Ke-Min Jen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

l. 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

{2}------------------------------------------------

Page_ 1 _of _1_

510 (K) NUMBER ( IF KNOW ): __ TBA____________________________________________________________________________________________________________________________________________ BIOTECH MANUAL WHEELCHAIR_ DEVICE NAME: C650 SERIES TOUR LIGHT WHEELCHAIR ____________________________________________________________________________________________________________________________________________

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 | 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 | K011701 |
|---------------|---------|
|---------------|---------|