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)

No FDA recalls found in the data synced 26 Oct 2026.

510(k) Number

K232198 ↗

FDA Product Code

IOR

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 →