# K992628: Firstclass Power Tilt and Recline Seat System, Model S400

- Pathway: 510(k) (Traditional)
- Applicant: Teftec Corp.
- Decided: Oct 25, 1999 after 81 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
The TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position. The FirstClass™ Power Tilt & Recline Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia’ Chronic Pain Bum Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Mutltiple Sclerosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list, anyone needing pressure relief or positional change that is unable to facilitate those movements independently would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

Source page: https://510kreport.com/device/K992628
Methodology: https://510kreport.com/methodology