FDA Registration
Active
🇨🇳 China
Tzumi FitRx Stimulator
Reg #: 3004264602
·
FEI: 3004264602
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SHANGHAI FOREIGN TRADE ENTERPRISES PUDONG CO., LTD.
- Registration Number
- 3004264602
- FEI Number
- 3004264602
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10-14 FL, No 258-268 Zhao Jia Bang Road,
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213788
Owner / Operator
- Firm Name
- Shanghai Foreign Trade Enterprises Pudong Co., Ltd.
- Operator Number
- 10081755
- Address
- 10-14 FL, No 258-268 Zhao Jia Bang Road,
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200031
- Country
- CN
- Correspondent
- Charles Shen
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Ridge
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-06-20 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2023-06-20 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2023-06-20 |
Proprietary Names
Tzumi FitRx Stimulator
Establishment Types
Export Device to the United States But Perform No Other Operation on Device