VARI-ABLE APB (ADAPTABLE POSITIONING BASE)

{0}------------------------------------------------ # OCT 7 - 2004 K042401 # 510(k) Summary ## Degage's Vari-Able APB Manual Wheelchair # Submitter's Name, Address, Telephone Number, Fax Number, Contact Person, and Date Prepared: American Track Roadsters, Inc. dba Degage 3535 South Kipling Parkway Lakewood, CO 80235 Phone (303) 986-9300 Fax (303) 986-9301 Contact Name: Greg Peek President Date Prepared: August 27, 2004 ### Name of Device and Name/Address of Sponsor: American Track Roadsters, Inc. dba Degage 3535 South Kipling Parkway Lakewood, CO 80235 Phone (303) 986-9300 Fax (303) 986-9301 Device Name: Vari-Able APB Common Name: Manual Wheelchair Classification Name: Wheelchair, Mechanica18910R Predicate Device: Labac MTC (K921136) #### Intended Use: The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to personswith a primary pediatric indication who are limited to a sitting position. ### Technological Characteristics and Substantial Equivaence: ### Device Description: The Vari-Able, APB (Adaptable Positioning Base) is a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system. It is designed to provide mobility and optimized positioning for patients who require long term accommodationdue to conditions of severe physical motion restriction. Patients with diagnosis such as cerebal palsy, would typically benefit from {1}------------------------------------------------ the use of the Vari-Able, APB (Adaptable Positioning Base). The product consists of a steel/aluminum frame, rear wheels (which can be substituted based on The product consists of a steering maility it and support, and other comports such as and manual patient requirements ,, a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and inandar adjustinents for other provided, the APB will positioning adjustment of the thi aligic, Willions and seating systems currently available in the market. The product is capable of many configurations of the frame, wheels, and components to accommodate The product is capable of many configurations of the neanual adjustments that can be made patients with difficult to solve positioning requirements. Using shorizments he chan patients with difficult to solve positioning requirements. Bulligate of the chair may be changed to accommodate the patient's needs. The Vari-Able APB (Adaptable Positioning Base) also features weight shifting capabilities using assist in The Vari-Able APB (Adaptable Postuoling Dass) and Teach Portuges of This also can assist in positioning and feeding. The product is designed to function indoors or outdoors on surfaces such as sidewalks and other public places. #### Substantial Equivalence: Substantial Equivalentially equivalent to the Labac MTC (K921136) due to similarities in materials, construction, configuration, indications, and use. Both devices are manually operated by the user or an attendant. Both devices provide mobility to Both devices are manually operated by the user of a tubular frame, four wheels (two persons limited to a sitting position. Doth devices feature a manual till-in-space as associated and large rear wheels, and two shian whools for blooling) - " we mgy - " we winize user comfort and positioning. ## Performance Data: Performance Data: The Vari-Able APB and the Labac MTC were tested using a methodology based on ANS/RESNA I he Var-Adle AFD and the Eabac MTC References and Test Methods for Wheelchairs (Including wheelchan Stalluards Volume 1-1776 - Requirements with and laterally, posteriorly, and anteriorly indicate the two devices are substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 7 - 2004 Mr. Gregory A. Peek President American Track Roadsters, Inc. Degage 3535 South Kipling Street Lakewood, Colorado 80235 Re: K042401 Trade/Device Name: Vari-Able, APB Mechanical Wheelchair Regulation Number: 21 CFR 890. 3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 16, 2004 Received: September 20, 2004 Dear Mr. Peek: 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 (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. {3}------------------------------------------------ Page 2 - Mr. Gregory A. Peek 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours. Sincerely yours, Mark A. Millbern 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K 042401 Device Name: Vari-Able, APB Mechanical Wheelchair Indications for Use: The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to persons with a primary pediatric indication who are limited to a sitting position. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Millhorn Orvision Sign-Division of General, Restorative, and Neurological Devices Page 1 of ____________________________________________________________________________________________________________________________________________________________________ **510(k) Number** K042410/