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))

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

510(k) Number

K260319 ↗

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 →