# K113577: Merits Model R Series Positioning System for Powered Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Merits Health Products Co., Ltd.
- Decided: May 8, 2012 after 155 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
Longest line of descent: 3 generations back to K960951 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021264: TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat, Motion Concepts (2002) Summary page 1.

## Indications for use
The Merits Model R series Positioning System for Powered Wheelchair is intended for people using a powered wheelchair and requiring positional change. Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of tilt and reclining seat back.

Source page: https://510kreport.com/device/K113577
Methodology: https://510kreport.com/methodology