Data / Medical devices / China / Jiangsu Assure Medical Equipment Co., Ltd

Jiangsu Assure Medical Equipment Co., Ltd: FDA-registered device maker in ZHENJIANG CITY Jiangsu, China, 5 510(k) clearances

Name: Jiangsu Assure Medical Equipment Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jiangsu Assure Medical Equipment Co., Ltd is registered with the FDA (registration 3033814356) in ZHENJIANG CITY Jiangsu, China. It lists 18 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 15, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033814356
Address: No. 799, CHUQIAO ROAD NO.39, Hengtong Road, ZHENJIANG CITY Jiangsu, China, 212009
Owner or operator: JIANGSU ASSURE MEDICAL EQUIPMENT CO LTD (10091590)
Roles: Contract manufacturer, Manufacturer
First device listed: October 17, 2024
Registered through: 2026
Brand names listed: ASSURE, Bariatric Heavy Duty Wheelchair, Bariatric Heavy duty wheelchair, Guardian K3 Wheelchair, Guardian Wheelchair Extra Wide, Guardian K3 Wheelchair Plus, Guardian K4 Wheelchair, Walgreens K, Guardian Reclining wheelchair Medline Industries, LP, K5, Medical Depot Inc, Medline Aluminum Commode Transport Shower Chair, Medline Transport Chair and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Armrest, Wheelchair	IML	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Attachment, Commode, Wheelchair	INB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Contract manufacturer	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Chair, With Casters	INM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Components, Wheelchair	KNN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Anti-Tip, Wheelchair	IMR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Footrest, Wheelchair	IMM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Restraint, Wheelchair, Non-Protective	KID	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Table, Mechanical	INW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tips And Pads, Cane, Crutch And Walker	INP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Contract manufacturer, Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2026	K260145	YJ-K1K2 Wheelchair (YJ-013F)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
September 15, 2026	K260144	Reclining wheelchair (YJ-013L)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
September 15, 2026	K260141	Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
September 15, 2023	K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
September 15, 2023	K232198	Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 15, 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.