Zhenjiang Assure Medical Equipment Co., Ltd. - FDA 510(k) Cleared Dev...
Recent clearances: Power wheelchair, YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE, 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)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zhenjiang Assure Medical Equipment Co., Ltd. Physical Medicine ✕
6 devices
Cleared
Dec 22, 2025
Power wheelchair
Physical Medicine
251d
Cleared
Oct 03, 2023
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE
Physical Medicine
68d
Cleared
Sep 15, 2023
Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S...
Physical Medicine
52d
Cleared
Sep 15, 2023
Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS
Physical Medicine
52d
Cleared
Jun 05, 2023
Zhenjiang Assure Mechanical Wheelchair,model:K1
Physical Medicine
28d
Cleared
Apr 18, 2012
ZHENJIANG ASURE MECHANICAL WHEELCHAIR
Physical Medicine
203d