# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.
- Decided: Sep 15, 2023 after 52 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: 4 generations back to K935398 (1994). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201461: Manual Wheelchair, Model A011, Ningbo Shenyu Medical Equipment Co.,Ltd (2021) Summary page 4.

## Most influential descendants
- K260144: Reclining wheelchair (YJ-013L) (2026), 0 descendants of its own
- K261571: Manual Wheelchair (H008, PCK7) (2026), 0 descendants of its own
- K260319: K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest (ELR) 18” with elevated foot rest (ELR) 20” with elevated foot rest (ELR)) (2026), 0 descendants of its own

## Indications for use
The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K232198
Methodology: https://510kreport.com/methodology