Data / Medical devices / China / Changzhou 3 Bears Import/Export Co. Ltd
Changzhou 3 Bears Import/Export Co. Ltd: FDA-registered device maker in Tianning District Jiangsu, China, 2 510(k) clearances
Changzhou 3 Bears Import/Export Co. Ltd is registered with the FDA (registration 3009302777) in Tianning District Jiangsu, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 6, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009302777
- Address
- 1 Xiqi Road Qinglong, Tianning District Jiangsu, China, 213017
- Owner or operator
- Changzhou 3 Bears Import/Export Co. Ltd (10086654)
- Roles
- Exporter to the US
- First device listed
- November 29, 2022
- Registered through
- 2026
- Brand names listed
- HVR1 Walker, HVR2 Bariatric Walker, HVX Wheelchair Components, HVX1 Wheelchair, HVX2 Wheelchair, HVX3 Max Wheelchair, HVX3 Wheelchair, Staxi Airport Chair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Exporter to the US | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Exporter to the US | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Exporter to the US | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Exporter to the US | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| July 6, 2009 | K091482 | HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 | IOR | Substantially Equivalent | Danyang Huayi Medical Supply & Equipment Co, Ltd. | accessdata.fda.gov |
| March 12, 2008 | K080207 | DANYANG HUAYI K2 AND K7 WHEELCHAIRS | IOR | Substantially Equivalent | Danyang Huayi Medical Supply & Equipment Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Mechanical
- All makers of Walker, Mechanical
- All makers of Chair, Adjustable, Mechanical
- All makers of Cushion, Wheelchair
- All makers of Accessories, Wheelchair
Updated July 6, 2009. 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.