ClearanceBrief
Company · CN

Zhenjiang Assure Medical Equipment Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (6 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IORWheelchair, Mechanical10
ITIWheelchair, Powered1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 16, 2026K261919Multifunctional wheelchair (YJ-059)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2026K260145YJ-K1K2 Wheelchair (YJ-013F)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2026K260144Reclining wheelchair (YJ-013L)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2026K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Mar 31, 2026K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Dec 22, 2025K251159Power wheelchair
Zhenjiang Assure Medical Equipment Co., Ltd., CN
ITI
Oct 3, 2023K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2023K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-01
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2023K232198Reclining 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)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Jun 5, 2023K231320Zhenjiang Assure Mechanical Wheelchair,model:K1
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Apr 18, 2012K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIR
Zhenjiang Assure Medical Equipment Co., Ltd., TW
IOR

Latest recalls

DateFirm and productCodeLinked 510(k)
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