Zhenjiang Assure Medical Equipment Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251159Power wheelchairDecember 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-KOctober 3, 2023
K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJSeptember 15, 2023
K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011September 15, 2023
K231320Zhenjiang Assure Mechanical Wheelchair,model:K1June 5, 2023
K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRApril 18, 2012