DELUXE MANUAL WHEELCHAIR HW 4000

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## SEP 1 3 2002 Forever Young Enterprise Company, LTD. c/o Ke-Min Jen, Ph.D. Roc Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin-Chu City China (Taiwan) Re: K022700 > Trade/Device Name: Deluxe Manual Wheelchair HW 4000 Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: July 30, 2002 Received: August 13, 2002 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ ### 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. L. Mark N. Millhiser 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 ### 510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: DELUXE MANUAL WHEELCHAIR HW4000 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___________________________________________________________________________________________________________________________________________________ ( Per 21 CFR 801.109 ) ( Optional Format 1-2-96 ) Mark N Millican n of General, Restorative 510(k) Number _