# K994241: TRX-CG Power Tilt and Recline System

- Pathway: 510(k) (Traditional)
- Applicant: Motion Concepts
- Decided: Jan 13, 2000 after 29 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.
- (no number) Tarsys Tilt and Recline System: named in the summary without a submission number

## Indications for use
The TRx-CG is appropriate for use by any individual who drives a Quickie G-424, S-52§, or an S-626 power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: 6. Comfort — As with any individual — able-bodied or disabled — changes in position are necessary to maintain a state of comfort. 7. Positioning — Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. 8. Pressure Relief or Reduction — Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers. The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.

Source page: https://510kreport.com/device/K994241
Methodology: https://510kreport.com/methodology