# K261571: Manual Wheelchair (H008, PCK7)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Aug 6, 2026 after 86 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: 5 generations back to K935398 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232198: Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF), Zhenjiang Assure Medical Equipment Co., Ltd. (2023) Summary page 5.

## Indications for use
The Manual Wheelchair is to provide mobility to people limited to sitting position.

Source page: https://510kreport.com/device/K261571
Methodology: https://510kreport.com/methodology