FDA Registration
Active
🇨🇳 China
THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD.
Reg #: 3008723825
·
FEI: 3008723825
·
Expires 2026
Products
6
Proprietary Names
23
Establishment Types
5
Classifications
6
Registration Details
- Registration Name
- THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD.
- Registration Number
- 3008723825
- FEI Number
- 3008723825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 Xiqi Road, Tianning
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K080207
Owner / Operator
- Firm Name
- THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD
- Operator Number
- 10034496
- Address
- 1 Xiqi Road, Qinglong, Tianning District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213017
- Country
- CN
US Agent
- Business Name
- Staxi Corp
- Contact Name
- Melanie Tomlinson
- Address
- 8 Willington Way
- City
- Newnan
- State
- GA
- ZIP
- 30265
- Country
- US
- [email protected]
- Phone
- 470 2042875 ext. 130
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2013-12-18 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2010-12-06 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2010-12-06 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2010-12-06 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2014-07-01 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2010-12-06 |
Proprietary Names
HVX3 Max Wheelchair
HVX2 Wheelchair
HVR1 Walker
HVR2 Bariatric Walker
Staxi Transport Chair Accessories
Staxi Transport Chair Cushions
HVX Wheelchair Components
Staxi Cub Chair
Staxi Boarding Chair
Staxi Guest Services Chair
Staxi Ally Chair
Staxi Transport Chair Components
Staxi Airport Chair
Staxi Aisle Chair
Staxi Max Chair
Staxi Pediatric Chair
Staxi Medical Chair
Staxi MRI Chair
Staxi Standard Medical Chair
Staxi Ranger Chair
Staxi Commercial Chair
Staxi Standard Chair
HVX1 Wheelchair
Establishment Types
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device