Changzhou 3 Bears Import/Export Co., Ltd.
Registered establishment in Tianning District, Jiangsu, China. 5 device types.
Changzhou 3 Bears Import/Export Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Walker, Mechanical, Cushion, Wheelchair and 3 other device types. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | CHANGZHOU 3 BEARS IMPORT/EXPORT CO. LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009302777 |
| FEI number | 3009302777 |
| Establishment type | Exporter |
Location
| City | Tianning District |
|---|---|
| Province | Jiangsu |
| Address | 1 Xiqi Road |
| Postal code | 213017 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | Staxi Transport Chair Accessories | 2022 | 80 |
| Chair, Adjustable, Mechanical | Class 1 | Staxi Max Chair, Staxi Standard Medical Chair, Staxi Pediatric Chair, HVX Wheelchair Components, Staxi Ally Chair, Staxi Aisle Chair and 10 more | 2022 | 46 |
| Cushion, Wheelchair | Class 1 | Staxi Transport Chair Cushions | 2022 | 53 |
| Walker, Mechanical | Class 1 | HVR1 Walker, HVR2 Bariatric Walker | 2022 | 183 |
| Wheelchair, Mechanical | Class 1 | HVX1 Wheelchair, HVX3 Wheelchair, HVX3 Max Wheelchair, HVX2 Wheelchair | 2022 | 46 |
Clearances
No clearance names Changzhou 3 Bears Import/Export 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 |
|---|---|---|---|---|
| K091482 | 2009-07-06 | IOR | Traditional | Danyang Huayi Medical Supply & Equipment Co., Ltd. |
| K080207 | 2008-03-12 | IOR | Traditional | Danyang Huayi Medical Supply & Equipment Co., Ltd. |
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.