Data / Medical devices / China / Three Bears (jiangsu) Healthcare Technology Co. Ltd.
Three Bears (jiangsu) Healthcare Technology Co. Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 2 510(k) clearances
Three Bears (jiangsu) Healthcare Technology Co. Ltd. is registered with the FDA (registration 3008723825) in Changzhou Jiangsu, China. It lists 6 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
- 3008723825
- Address
- 1 Xiqi Road Tianning, Changzhou Jiangsu, China, 213017
- Owner or operator
- THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD (10034496)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- December 6, 2010
- Registered through
- 2026
- Brand names listed
- HVR1 Walker, HVR2 Bariatric Walker, HVX Wheelchair Components, HVX1 Wheelchair, HVX2 Wheelchair, HVX3 Max Wheelchair, Staxi Airport Chair, Staxi Aisle Chair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Exporter to the US, Foreign private label distributor | 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 Chair, Adjustable, Mechanical
- All makers of Cushion, Wheelchair
- All makers of Accessories, Wheelchair
- All makers of Walker, Mechanical
- All makers of Components, 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.