# K252828: Manual Wheelchair (W47)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd.
- Decided: Dec 5, 2025 after 91 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K101277 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170517: Merits Model R106/R136 Rehab Wheelchair, Merits Healthcare Industries (Suzhou) Co., Ltd. (2017) Summary page 6.

## Indications for use
The W47 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K252828
Methodology: https://510kreport.com/methodology