Three Bears (Jiangsu) Healthcare Technology Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 6 device types, 1 product catalogued.
Three Bears (Jiangsu) Healthcare Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Walker, Mechanical, Cushion, Wheelchair and 4 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008723825 |
| FEI number | 3008723825 |
| DUNS | 421265882 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Location
| City | Changzhou |
|---|---|
| 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 | 2010 | 80 |
| Chair, Adjustable, Mechanical | Class 1 | Staxi Boarding Chair, Staxi Ranger Chair, Staxi MRI Chair, Staxi Ally Chair, Staxi Cub Chair, Staxi Standard Chair and 9 more | 2010 | 46 |
| Components, Wheelchair | Class 1 | HVX Wheelchair Components | 2014 | 54 |
| Cushion, Wheelchair | Class 1 | Staxi Transport Chair Cushions | 2010 | 53 |
| Walker, Mechanical | Class 1 | HVR2 Bariatric Walker, HVR1 Walker | 2010 | 183 |
| Wheelchair, Mechanical | Class 1 | HVX1 Wheelchair, HVX2 Wheelchair, HVX3 Max Wheelchair | 2013 | 46 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Staxi | INN | 9 |
Clearances
No clearance names Three Bears (Jiangsu) Healthcare Technology 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. |
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.