Zhenjiang Assure Medical Equipment Co Ltd
Registered establishment in Zhenjiang, Jiangsu, China. 18 device types, 7 clearances.
Zhenjiang 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 2008.
Registration
| Registered name | ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007309323 |
| FEI number | 3007309323 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 镇江艾康医疗器械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Zhenjiang |
|---|---|
| Province | Jiangsu |
| Address | No.297/799, Chuqiao road |
| Postal code | 212009 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | 2008 | 80 | |
| Adaptor, Hygiene | Class 1 | 2012 | 193 | |
| Armrest, Wheelchair | Class 1 | 2008 | 29 | |
| Attachment, Commode, Wheelchair | Class 1 | 2008 | 70 | |
| Brake, Extension, Wheelchair | Class 1 | Medical Depot Inc | 2022 | 19 |
| Chair, With Casters | Class 1 | 2012 | 85 | |
| Components, Wheelchair | Class 1 | 2008 | 54 | |
| Cushion, Wheelchair | Class 1 | 2008 | 53 | |
| Device, Anti-Tip, Wheelchair | Class 1 | 2008 | 22 | |
| Footrest, Wheelchair | Class 1 | 2008 | 25 | |
| Restraint, Wheelchair, Non-Protective | Class 1 | Medline Industries, LP, Medical Depot Inc | 2024 | 15 |
| Sling, Arm | Class 1 | Medical Depot Inc | 2024 | 126 |
| Stand, Infusion | Class 1 | Medline Industries, LP, Medical Depot Inc | 2023 | 75 |
| Table, Mechanical | Class 1 | 2017 | 46 | |
| Tips And Pads, Cane, Crutch And Walker | Class 1 | 2008 | 69 | |
| Walker, Mechanical | Class 1 | 2008 | 183 | |
| Wheelchair, Mechanical | Class 1 | Medline Industries, LP, Medical Depot Inc, Guardian wheelchair,MEDLINE wheelchair,Mechanical, K5, guardian pediatric wheelchair Medline Industries, LP | 2017 | 46 |
| Wheelchair, Powered | Class 2 | Power Wheelchair EL-001 | 2026 | 62 |
Clearances
7 clearances name Zhenjiang 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.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260319 | 2026-03-31 | IOR | Traditional | This company |
| K251159 | 2025-12-22 | ITI | Traditional | This company |
| K232230 | 2023-10-03 | IOR | Traditional | This company |
| K232198 | 2023-09-15 | IOR | Traditional | This company |
| K232199 | 2023-09-15 | IOR | Traditional | This company |
| K231320 | 2023-06-05 | IOR | Special | This company |
| K112816 | 2012-04-18 | IOR | Traditional | This company |
| K053574 | 2006-01-25 | IOR | Traditional | Medline Industries, Inc. |
| K013761 | 2001-12-06 | IOR | Traditional | Medline Industries, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 1300+ |
|---|---|
| Factory area | 179,000 square meters |
| Main products | manual wheelchairs, electric wheelchairs, rollators, commode chairs, reclining wheelchairs |
| Certifications | FDA, CE, ISO13485 |
| Export markets | Colombia, Germany, Russia (implied global presence) |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Jiangsu Assure Medical Equipment Co., Ltd. | 18 |
| Zhenjiang Kawaza Medical Products Co., Ltd. | 10 |
| Jiangsu Andycare Medical Products Co., Ltd. | 8 |
| Rongxing Plastic Jurong Co., Ltd. | 8 |
| Jiangsu Taojing Co., Ltd. | 7 |
| ZUO Chuan Eyewear Co., Ltd., Danyang City | 5 |
| TR Optical Mfg Co., Ltd. | 4 |
| Universe Optical MFG Co., Ltd. | 4 |
| Mind Optical Co., Ltd. | 3 |
| Zhenjiang Dingfeng Needle Manufacturing Technology Co., Ltd. | 1 |
| Danyang Zhongyi Optical Glasses Co., Ltd. | 1 |
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.