# K122357: Merits Model P322FWD Powered Wheelchair

- Pathway: 510(k) (Abbreviated)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Jan 9, 2013 after 159 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 K090108 (2009). 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)
- K090108: Hoveround Teknique FWD MK4 Power Wheelchair, Hoveround Corp. (2009) Summary page 1.

## Recalls of this device
- Apr 1, 2021 · Class II · Z-1504-2021: Seat baseplate pin has broken in the field.

## Indications for use
The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Source page: https://510kreport.com/device/K122357
Methodology: https://510kreport.com/methodology