Zhenjiang Assure Medical Equipment Co., Ltd.

FDA Regulatory Profile

Zhenjiang Assure Medical Equipment Co., Ltd. appears in FDA public data with 0 recalls, 11 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Sep 16, 2026.

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K261919Multifunctional wheelchair (YJ-059)Sep 16, 2026
K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Sep 15, 2026
K260145YJ-K1K2 Wheelchair (YJ-013F)Sep 15, 2026
K260144Reclining wheelchair (YJ-013L)Sep 15, 2026
K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footresMar 31, 2026
K251159Power wheelchairDec 22, 2025
K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-KOct 3, 2023
K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011Sep 15, 2023
K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJSep 15, 2023
K231320Zhenjiang Assure Mechanical Wheelchair,model:K1Jun 5, 2023
K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRApr 18, 2012