BIOTECH POWERED WHEELCHAIR, C650PW

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JAN 1 8 2002 Mr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan) Re: K011846 Trade/Device Name: Biotech Powered Wheelchair C650PW Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: December 15, 2001 Received: December 21, 2001 Dear Mr. Ke-Min : We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren or the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal the energe, 1976, the enactment date of the Medical Device Amendments, or to conninetee prior to May 20, 1978, are occordance 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, are every inians of the Act include requirements for annual registration, listing of genced oonly of of recturing 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 If your device is elassinod (oor a 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 I heast of action that I British that your device complies with other requirements of the Act that I Dr Hao Intatutes and regulations administered by other Federal agencies. You must or any I odotal the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R ratt 807), adoming (QS) regulation (21 CFR Part 820); and if applicable. the electronic fordint and quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - Mr. Jen Ke-Min This letter will allow you to begin marketing your device as described in your Section 510(k) The States of the supply of all and section as also legally This letter will allow you to begin makemily your worner of your device of your device to a legally premarket notification. The FDA finding of substantial equivalence of you premarket notification. The FDA finding of subsanial equivalence or ... 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 If you desire specific advice for your device on our career, please contact the Office of additionally 21 CFR Part 809.10 for in vitte diagnostic devices, phease contact on a additionally 21 CFR Part 809. In the only, for questions on the promotion and advertising of Compliance at (301) 594-4659. Additionally, for questions on the Compliance at (301) 594-4659. Additionally, for questions of Co., Also, please note the your device, please confact the Office of Collighton's ("(21CFR Part 807.97). regulation entitled, "Misbranding by reference to premarket not may be obtained from the regulation entitled, "Misbranding by relevise the Act may be obtained from the firom the Other general information on your responsibilities under the Act may be obtained from Other general information on your responsional and Consumer Assistance at its toll-free number Division of Small Manufacturers, International and Consumer Assistance at its t Division of Sinan Manufacts, or at its Internet address (800) 656-2011-02-11 02 \/cdrh/dsma/dsmamain.html Sincerely yours, Sincerely yours, 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 0 {2}------------------------------------------------ Page_1_of_1_ 510 (K) NUMBER ( IF KNOW ): __ TBA BIOTECH POWERED WHEELCHAIR C650 PW DEVICE NAME: 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 ( Per 21 CFR 801.109 ) OR Over - The - Counter - Use_ ( Optional Format 1-2-96 ) Murle A. Millican Division of General, Restorative ad Neurological Devices 10(k) Number -