ALPHATRAC, MODEL A200 by TEFTEC CORP.

Alpha Trac design definitions and functional parameters are indicated for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gail 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 AlphaTrac 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) Parkinson's Amputees Brown Sequard's Syndrome and resultant paralysis Severe Arthritics (RA) (OA) Multiple Sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Huntington's Corea Traumatic Brain Injury (TBI) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal weakness Quadriparesis Paranaresis Cercural vascular Accident (C < H or Stroke)

This is not meant to be an all inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an 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.

Device Description

AlphaTrac™ Powered Wheelchair

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a powered wheelchair, not a study describing acceptance criteria and device performance based on a clinical study. Therefore, I cannot provide the requested information.

The document states that the FDA has reviewed the 510(k) notification for the AlphaTrac™ Powered Wheelchair and determined it to be "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence determination means that the device is considered as safe and effective as a legally marketed predicate device, and thus does not require a new premarket approval (PMA) based on a full clinical trial demonstrating safety and effectiveness.

For devices cleared through the 510(k) pathway, the "acceptance criteria" are generally established by demonstrating substantial equivalence to a predicate device, often through bench testing, non-clinical performance testing, and sometimes limited clinical data showing that the new device performs as intended and introduces no new safety or effectiveness concerns compared to the predicate. The FDA letter is not a report detailing such testing or setting specific performance metrics and outcomes.

To answer your questions, I would need a clinical study report or a 510(k) submission that includes performance testing and clinical data. This document does not contain that information.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

Mr. Thomas E. Finch III Vice President Teftec Corporation 6929 Old Spring Branch Road Spring Branch, Texas 78070

Re: к982815 AlphaTrac™ Powered Wheelchair Trade Name: Regulatory Class: II Product Code: ITI Dated: August 6, 1998 Received: August 7, 1998

Dear Mr. Finch:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Thomas E. Finch III

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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· 510 (k) NUMBER (IF KNOWN) :

K982815

DEVICE NAME:

AlphaTrac-Powered Wheelchair

INDICATIONS FOR USE:

Indications for use for the Alpha Trac powered wheelchair base:

bicoleto

aneral Restorative

If you have an 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)

Over-The-Counter-Use
(Optional Format 1 - 2 - 96)

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).