ALPHATRAC, MODEL A 205

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle are three stylized human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Teftec Corporation Thomas E. Finch III Vice President, Engineering 12450 Network Boulevard San Antonio, Texas 78249 Re: K022652 Trade/Device Name: AlphaTrac® Model A 205 Regulation Number: 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 7, 2002 Received: November 8, 2002 Dear Mr. Finch: 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 devec 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 {1}------------------------------------------------ Page 2 - Mr. Thomas E. Finch III 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. 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 (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. Miriam C. Provost Co Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 510 (k) NUMBER (IF KNOWN): K Č > 22 > Š > 22 > DEVICE NAME: Model A205 AlphaTrac® Powered Wheelchair INDICATIONS FOR USE: Indications for use for the Model A205 AlphaTrac® Powered Wheelchair base: AlphaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the AlphaTrace with no modifications. This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Sclerosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for a AlphaTrac powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility. If you have any further questions, please feel free to contact us directly. ## (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) | | Revised 11/13/1998 OR Over-The-Counter-Use Miriam C. Provost (Optional Format 1-2-96) (Division Sign-Off Division of General, Restorative and Neurological Devices 510(k) Number K022652