# K982815: Alphatrac, Model A200

- Pathway: 510(k) (Traditional)
- Applicant: Teftec Corp.
- Decided: Nov 6, 1998 after 87 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Indications for use for the Alpha Trac powered wheelchair base: Alpha Trac 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 gaxt 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 Hemiplegia Tetraplegia . Proximal weakness Quadriparesis Paraparesis Cercutad vascutal Acuiiiviii (U v A OF JUIFOKE) 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. If you have an further questions please feel free to contact us directly.

Source page: https://510kreport.com/device/K982815
Methodology: https://510kreport.com/methodology