CAT ACTIVE WHEELCHAIR

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Movingpeople.net c/o Mr. Mark Job 510(k) Program Manager TÜV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112 MAR 2 1 2002 Re: K020737 Trade/Device Name: CAT Active Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 5, 2002 Received: March 6, 2002 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. 9 re(s) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978) in occordance with the provisions of the Federal Food, Drug, de necs that have been receases of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controll provisions of ractice, 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 classinod controls. Existing major regulations affecting your device can mary of Sablet to Sack as alon a would be marts 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 lease be actived that i Dr o retion that your device complies with other requirements of the Act that I Drimas made a comd regulations administered by other Federal agencies. You must or uny I vathar bather 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 CI It Fat 607); adoming (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic rord in and quinty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - Mr. Mark Job 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 premarket notification. The FDA mianing of casification 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 devices diagnostic devices), please contact the Office of additionally 21 CI K Far 807.10 for questions on the promotion and advertising of Compliance at (301) 594-4637. The Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). It gulation cultured, "Misonanaing of roomsibilities under the Act may be obtained from the Other general information on your responsional 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, 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}------------------------------------------------ K020737 Page 510(k) Number (if known): K 0207377 Device Name: Cat Indications For Use: The Cat multi-functional active wheelchair manufactured by movingpeople.net is intended for frs by person(s) limited to a sitting position. It is designed to increase functionality for the person(s) by person(o) in The Cat was designed to increase functionality. The most natural postures and movements that people use during the day, have been analyzed, described and resulted in a mechanism that is individually adjusted. This is know as the IPPA. IPPA stands for Intelligent Posture and Purpose Adjustments. It means that you get a mechanism with which you can change your sitting posture in a second into the best desired position. (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801 109) or for Mark N. Millaras Division of General, Restorative and Neurological Devices 510(k) Number_ SKST Over-The-Counter Use (Optional format 1-2-96) \$\stackrel{m}{I}\$ но 1 заатн