# K023426: TRX Vertical Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Motion Concepts
- Decided: Nov 21, 2002 after 41 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963817 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963817: Levo Mobil LCM, Levo USA (1997) Summary page 1.

## Recalls of this device
- Aug 28, 2014 · Class II · Z-2657-2014: Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).

## Indications for use
The TRX Vertical Positioner is appropriate for use by any individual who drives a 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: All positioning benefits associated with the tilt/recline product - Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort. Repositioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure relief - Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual’s orientation in space, pressures caused by gravity will shift. Positioning Versatility - Individuals are able to reach higher elevations, increasing their range of motion and accessibility. The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline, and elevating functions already available in with the TRX Power Positioning System defined in K021264. 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 Vertical Positioners are to be installed ONLY by qualified Dealers.

Source page: https://510kreport.com/device/K023426
Methodology: https://510kreport.com/methodology