C.T.M. POWER CHAIR, MODEL HS-2800

{0}------------------------------------------------ ## AUG 0 2 2002 K021617 ## 510(k) SUMMARY C.T.M. Homecare Product, Inc. Submitter's Name: 1663 Iowa Ave. Riverside, CA 92507 (909) 788-8168 Date summary prepared: May 14, 2002 Device name: Proprietary name: Common or usual name: Classification name: C.T.M. Power Chair HS-2800 Power chair. Powered wheelchair, Class II, 21 CFR 890.3860. Legally marketed device for substantial equivalence comparison: Jazzy Power Chair submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) *K945936. Description of the device: The C.T.M. Power Chair HS-2800 is an indoor/outdoor powered wheelchair that is battery operated. It has a base with six wheels, an adjustable padded seat with armrests, and a controller attached to one armrest which allows the rider to control the movement of the chair. It can be disassembled for transport and is provided with an on-board battery charger. Intended use of device: The device is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person. Technological characteristics: The device features and use parameters of the C.T.M. Power Chair HS-2800 and Jazzy Power Chair are very similar. Both are battery operated, have two motors, and have automatic braking systems. Batteries and charging recommendations are identical. Built-in battery chargers are provided with both wheelchairs. Use parameters are very similar, varying only in minor parameters such as curb height and grade climbable of the respective wheelchairs. Testing conducted: Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission. Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k). {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 0 2 2002 C.T.M. Homecare Product, Inc. Robert S. McQuate c/o R. S. McQuate and Associates 3636 East Columbine Drive Phoenix, Arizona 85032 Re: K021617 Trade Name: C.T. M. Power Chair HS-2800 Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 14, 2002 Received: May 16, 2002 Dear Mr. McQuate: We have reviewed your Section 510(k) premarket 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 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 (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. {2}------------------------------------------------ Page 2 - Mr. Robert S. McQuate 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, Mark McMillan 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 {3}------------------------------------------------ ## Indications for Use Statement 510(k) Number ( if known): Device name: C.T.M. Power Chair HS-2800 Indications for Use: The C.T.M. Power Chair HS-2800 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person. > (Please do not write below this line) ----------------------------------------------------- Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Mark N. Milliman (Division Sign-Off) Division of General. Restorative and Neurological Devices 510(k) Number _