Arjo (Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 2 device types.
Arjo (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sleeve, Limb, Compressible, Mattress, Air Flotation, Alternating Pressure. Its earliest product listing with the FDA dates from 2002.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3005619970 |
| FEI number | 3005619970 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 侒捷祐（苏州）医疗设备贸易有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 158 Fangzhou Road |
| Postal code | 215024 |
| Country | China |
What It Makes
Clearances
No clearance names Arjo (Suzhou) Co., Ltd. as applicant. 3 are held by other companies 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 |
|---|---|---|---|---|
| K143438 | 2015-06-23 | JOW | Traditional | Getinge (Suzhou) Co., Ltd. |
| K133119 | 2014-02-28 | JOW | Traditional | Arjohuntleigh Polska SP Z.O.O. |
| K010744 | 2002-03-26 | JOW | Traditional | Huntleigh Healthcare Ltd. |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-15 | Class II | Under Investigation by firm | There is a potential for abnormal inflation of the mattress. | 13042 units | 2023-11-13 |
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.