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)

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K232199 ↗

FDA Product Code

IOR

Models / Variants

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)

FDA applicant

Zhenjiang Assure Medical Equipment Co., Ltd.

Device Class

Class I

Regulation

21 CFR Part 890.3850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Rollator

  Class I

  CE/MDR

• Multifunctional wheelchair (YJ-059)

  Class I

  FDA 510(k) K261919 Active Cleared 16 Sep 2026

• Bariatric Heavy Duty Wheelchair (YJ-010V)

  Class I

  FDA 510(k) K260141 Active Cleared 15 Sep 2026

• Reclining wheelchair (YJ-013L)

  Class I

  FDA 510(k) K260144 Active Cleared 15 Sep 2026

• YJ-K1K2 Wheelchair (YJ-013F)

  Class I

  FDA 510(k) K260145 Active Cleared 15 Sep 2026

• Wheelchair

  Class I

  CE/MDR

See all devices from Zhenjiang Assure Medical Equipment Co., Ltd →