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Data / Medical devices / China / Zhenjiang Assure Medical Equipment Co Ltd

Zhenjiang Assure Medical Equipment Co Ltd: FDA-registered device maker in ZHENJIANG CITY Jiangsu, China, 11 510(k) clearances

Zhenjiang Assure Medical Equipment Co Ltd is registered with the FDA (registration 3007309323) in ZHENJIANG CITY Jiangsu, China. It lists 18 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Zhenjiang Assure Medical Equipment Co Ltd
FDA registration number
3007309323
Address
No.297/799, Chuqiao road NO.39, Hengtong Road, ZHENJIANG CITY Jiangsu, China, 212009
Owner or operator
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD (10027294)
Roles
Contract manufacturer, Manufacturer
First device listed
October 21, 2008
Registered through
2026
Brand names listed
Bariatric Heavy Duty Wheelchair, Comfort tilt-in-space chair, Guardian wheelchair,MEDLINE wheelchair,Mechanical, K5, Medical Depot Inc, Medline Industries, LP, POWER WHEELCHAIR EL-001, YJ-013F and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Contract manufacturer, Manufactureraccessdata.fda.gov
Adaptor, HygieneILS1Contract manufacturer, Manufactureraccessdata.fda.gov
Armrest, WheelchairIML1Contract manufacturer, Manufactureraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Contract manufacturer, Manufactureraccessdata.fda.gov
Brake, Extension, WheelchairIMW1Contract manufacturer, Manufactureraccessdata.fda.gov
Chair, With CastersINM1Contract manufacturer, Manufactureraccessdata.fda.gov
Components, WheelchairKNN1Contract manufacturer, Manufactureraccessdata.fda.gov
Cushion, WheelchairIMP1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Anti-Tip, WheelchairIMR1Contract manufacturer, Manufactureraccessdata.fda.gov
Footrest, WheelchairIMM1Contract manufacturer, Manufactureraccessdata.fda.gov
Restraint, Wheelchair, Non-ProtectiveKID1Contract manufacturer, Manufactureraccessdata.fda.gov
Sling, ArmILI1Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Table, MechanicalINW1Contract manufacturer, Manufactureraccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Contract manufacturer, Manufactureraccessdata.fda.gov
Walker, MechanicalITJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Wheelchair, MechanicalIOR1Contract manufacturer, Manufactureraccessdata.fda.gov
Wheelchair, PoweredITI2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 16, 2026K261919Multifunctional wheelchair (YJ-059)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 15, 2026K260145YJ-K1K2 Wheelchair (YJ-013F)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 15, 2026K260144Reclining wheelchair (YJ-013L)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 15, 2026K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
December 22, 2025K251159Power wheelchairITISubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
October 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 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 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-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 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)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
April 18, 2012K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRIORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
January 25, 2006K053574MEDLINE PEDIATRIC WHEELCHAIRSIORSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
December 6, 2001K013761MEDLINE EXCEL RECLINCER WHEELCHAIRIORSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov

Compare with other makers

Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.