Jiangsu Assure Medical Equipment Co., Ltd.

Registered establishment in Zhenjiang, Jiangsu, China. 18 device types.

Registry build 21.09.26

Jiangsu Assure Medical Equipment Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sling, Arm, Stand, Infusion and 16 other device types. Its earliest product listing with the FDA dates from 2024.

Registration

FDA registration record for Jiangsu Assure Medical Equipment Co., Ltd.
Registered name JIANGSU ASSURE MEDICAL EQUIPMENT CO., LTD
Status Registered
Registration expires 2026
Registration number 3033814356
FEI number 3033814356
Establishment type Contract manufacturer, Manufacturer

Location

Address of Jiangsu Assure Medical Equipment Co., Ltd.
City Zhenjiang
Province Jiangsu
Address No. 799, CHUQIAO ROAD
Postal code 212009
Country China

What It Makes

Device types Jiangsu Assure Medical Equipment Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Wheelchair Class 1 Assure 2024 80
Adaptor, Hygiene Class 1 Assure 2024 193
Armrest, Wheelchair Class 1 Assure 2024 29
Attachment, Commode, Wheelchair Class 1 Assure 2024 70
Belt, Wheelchair Class 1 Safety belt 2026 24
Brake, Extension, Wheelchair Class 1 Assure 2024 19
Chair, With Casters Class 1 Assure, Medline Aluminum Commode Transport Shower Chair, Medline Transport Chair 2024 85
Components, Wheelchair Class 1 Assure 2024 54
Cushion, Wheelchair Class 1 Assure 2024 53
Device, Anti-Tip, Wheelchair Class 1 Assure 2024 22
Footrest, Wheelchair Class 1 Assure 2024 25
Restraint, Wheelchair, Non-Protective Class 1 Assure 2024 15
Sling, Arm Class 1 Medical Depot Inc 2025 126
Stand, Infusion Class 1 Assure 2024 75
Table, Mechanical Class 1 Assure 2024 46
Tips And Pads, Cane, Crutch And Walker Class 1 Assure 2024 69
Walker, Mechanical Class 1 Assure 2024 183
Wheelchair, Mechanical Class 1 Guardian K3 Wheelchair, Guardian Wheelchair Extra Wide, Guardian K3 Wheelchair Plus, Guardian K4 Wheelchair, Walgreens K, Guardian Reclining wheelchair Medline Industries, LP, Medline K5166N21E1 K5166N21S1 K5186N21E1 K5186N21S1 K5206N21E1 K5206N21S1, K5, Reclining wheelchair, Assure and 2 more 2024 46

Clearances

No clearance names Jiangsu Assure Medical Equipment Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Jiangsu Assure Medical Equipment Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K232198 2023-09-15 IOR Traditional Zhenjiang Assure Medical Equipment Co Ltd
K232199 2023-09-15 IOR Traditional Zhenjiang Assure Medical Equipment Co Ltd

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangsu Assure Medical Equipment Co., Ltd.
Founded 2007
Employees 1300+
Factory area 179000
Main products Wheelchairs, Electric power wheelchairs, Rollators, Reclining chairs, Commode chairs
Certifications FDA, CE, ISO13485
Export markets International

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer