FDA Registration
Active
🇨🇳 China
Band or Belt Pelvic Support (Proprietary Name)
Reg #: 3034694939
·
FEI: 3034694939
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ABLETECH ORTHOPEDICS CORPORATION
- Registration Number
- 3034694939
- FEI Number
- 3034694939
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15F-3 No.1 Baosheng Rd., Yonghe Dist.
- City
- New Taipei City Taiwan
- Country
- CN
Owner / Operator
- Firm Name
- Abletech Orthopedics Corporation
- Operator Number
- 10092117
- Address
- 15F-3 No.1 Baosheng Rd., Yonghe Dist.
- City
- New Taipei City
- State
- Taiwan
- Postal Code
- 234635
- Country
- CN
- Correspondent
- Ramon Tseng
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2024-12-05 |
Proprietary Names
Band or Belt Pelvic Support (Proprietary Name)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)