# K201461: Manual Wheelchair, Model A011

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Shenyu Medical Equipment Co.,Ltd
- Decided: May 21, 2021 after 353 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: 3 generations back to K935398 (1994). 3 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181795: AST Model MA012 and MS019 Rehab Wheelchair, Sichuan Ast Medical Equipment Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- 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) (2023), 3 descendants of its own
- K232230: YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) (2023), 2 descendants of its own
- K232199: Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) (2023), 1 descendant of its own
- K261919: Multifunctional wheelchair (YJ-059) (2026), 0 descendants of its own
- K260144: Reclining wheelchair (YJ-013L) (2026), 0 descendants of its own

## Indications for use
The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K201461
Methodology: https://510kreport.com/methodology