EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAR 8 2002 ENSD Corporation c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127 Re: K020094 Trade/Device Name: EN 600-658 Standard Wheelchair EN 600-666 Standard Wheelchair EN 600-664 Standard Wheelchair EN 600-690 Extra Wide Wheelchair EN 600-651 Aluminum Light Weight Wheelchair-29 Ibs EN 600-663 Light Weight Wheelchair-32 lbs EN 600-665 Standard Wheelchair EN 600-670 Reclinable Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: January 10, 2002 Received: January 11, 2002 Dear Mr. Walls: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and the Medical Device Amendments, or to commerce prior to May 20, 1978, and email of the provisions of the Federal Food, Drug, devices that have boon recidential in quire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that Go not request of the general controls provisions of the Act. The I ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of use tice, 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 (500 a00 roy ass. 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 be found in the Our cements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Kevin Walls, RAC 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.Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 Oivision 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. Sincerely yours, Mark Mllkerson 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 known): |< O L O O O O O O O O O O O O O O O O O O O O O O O O O O EN 600-658 Standard Wheelchair Device Name: EN 600-666 Standard Wheelchair EN 600-664 Standard Wheelchair EN 600-690 Extra Wide Wheelchair EN 600-651 Alum. Light Weight Wheelchair-29lbs EN 600-663 Light Weight Wheelchair-32lbs EN 600-665 Standard Wheelchair EN 600-670 Reclinable Wheelchair Indications for Use: The EN 600-658, EN 600-666, EN 600-664, EN 600-664, EN 600-690, EN 600-6 151, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchats are manually operated devices with wheels that are 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 IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) OR 510(k) Number. Over the Counter Use _X Division of General, Restorative and Newslogical Devices