# Zhenjiang Assure Medical Equipment Co., Ltd.

- Location (FDA's records): Zhenjiang City, CN
- FDA decisions: 11 (2012–2026): 11 510(k) clearances
- Product codes: IOR (10), ITI (1)
- 510(k) review time since 2016: median 84 days, against 97 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 9 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ningbo Shenyu Medical Equipment Co.,Ltd: 4 (https://510kreport.com/company/ningbo-shenyu-medical-equipment)
- Guangdong Kaiyang Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/guangdong-kaiyang-medical-technology)
- Kunshan Hi-Fortune Health Products Co., Ltd.: 1 (https://510kreport.com/company/kunshan-hi-fortune-health-products)

## Firms that cite its devices most
- Valentine Intl., Ltd.: 1 (https://510kreport.com/company/valentine-intl)
- Anhui Jbh Medical Apparatus Co., Ltd.: 1 (https://510kreport.com/company/anhui-jbh-medical-apparatus)
- Strongback Mobility AG C/O Blueaudit GmbH: 1 (https://510kreport.com/company/strongback-mobility-ag-c-o-blueaudit)
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-yuyue-medical-equipment-supply)

## Its most-cited devices
- 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), cited by 3
- K112816: Zhenjiang Asure Mechanical Wheelchair (2012), cited by 2
- 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), cited by 2
- 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), cited by 1
- K231320: Zhenjiang Assure Mechanical Wheelchair,model:K1 (2023), cited by 1

## Recent decisions
- K261919: Multifunctional wheelchair (YJ-059) (Sep 16, 2026)
- K260144: Reclining wheelchair (YJ-013L) (Sep 15, 2026)
- K260141: Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) (Sep 15, 2026)
- K260145: YJ-K1K2 Wheelchair (YJ-013F) (Sep 15, 2026)
- 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)) (Mar 31, 2026)
- K251159: Power wheelchair (Dec 22, 2025)
- 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) (Oct 3, 2023)
- 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) (Sep 15, 2023)

Source page: https://510kreport.com/company/zhenjiang-assure-medical-equipment