RENEGADE WHEELCHAIR

{0}------------------------------------------------ Submitter: Alpha One Renegade Wheelchair Traditional 510(k) K082857 ## 510(k) SUMMARY- Renegade Wheelchair Submitter Name: Submitter Address: Alpha One 127 Main Street Portland, Maine 04106 Brad Strause 207-767-2189 207-799-8346 IOR and IQC Contact Person: Phone Number: Fax Number: Date Prepared: September 24, 2008 Renegade Wheelchair Device Trade Name: Mechanical special grade wheelchair Name: Classification Device Common Numbers: Classification Names: Product Codes: Predicate Devices: Statement of Intended Device Description: Use: Stryker Sorano Wheelchair (K051369) 21 CFR 890.3850 and 21 CFR 890.3880 Poirier S.A. Arnas Wheelchair (K840631) The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use. Wheelchair, Mechanical and Wheelchair, Special Grade The Renegade is designed to offer the user the option of conventional hand-to-wheel propulsion, or the use of pushbar levers which provide thrust by way of a gear and chain system. Each wheel has multiple gears and independent brakes, providing versatility and control. The wheelchair is fitted with accessory holders to provide a means to carry sports and recreational equipment. Comparison to the This device, with respect to material composition, technical Predicate Devices: characteristics, and intended use, is substantially equivalent to the predicate devices. JAN - 6 2009 Section 5.0 {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Alpha One % Trisler Consulting, LLC Ms. Pastv J. Trisler 5600 Wisconsin Ave, Suite 509 Chevy Chase, Maryland 20815 Re: K082857 Trade Name: Renegade Wheelchair Regulation Number: 21 CFR 890.3880 Regulation Names: Special grade wheelchair Regulatory Class: II Product Code: IOC Dated: December 10, 2008 Received: December 12, 2008 ### Dear Ms. Trisler: 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. JAN - 6 2009 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 -- Ms. Pasty J. Trisler 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N Millican Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Submitter: Alpha One 510(k) Number (if known): Device Name: Renegade Wheelchair Indications for Use: The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) (Posted November 13, 2003) Mark A. Milliken (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K082857 . .