FDA Registration
Active
🇨🇳 China
CELE L5, CELE L3, CELE L1 Aero Runner Treadmill; VR10, VR08, VR06, VR04, VR02 Treadmill; GA1000, GA1080,
Reg #: 3034728798
·
FEI: 3034728798
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TIANJIN GOLDENALL MEDICAL DEVICE CO.,LTD
- Registration Number
- 3034728798
- FEI Number
- 3034728798
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.1, Hengyuan Road, Jingbin Industrial Park Wuqing District
- City
- Tianjin city
- Country
- CN
Owner / Operator
- Firm Name
- Tianjin GoldenAll Medical Device Co.,LTD
- Operator Number
- 10092155
- Address
- No.1, Hengyuan Road, Jingbin Industrial Park, Wuqing District
- City
- Tianjin city
- State
- CN-NOTA
- Postal Code
- 301700
- Country
- CN
- Correspondent
- Chengcheng Chu
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 |
|---|---|---|---|---|---|
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2024-12-10 |
Proprietary Names
CELE L5, CELE L3, CELE L1 Aero Runner Treadmill; VR10, VR08, VR06, VR04, VR02 Treadmill; GA1000, GA1080,
GA60, GA20, AERO GSP15, AERO SP15, AERO S15, AERO GP15, AERO P15, AERO P15R, AERO 15, AERO 15R,
AERO GSP8, AERO SP8, AERO S8, AERO GP8, AERO P8, AERO P8R, AERO 8, AERO 8R, AERO GSP5, AERO SP5,
AERO 10, AERO 20, AERO 100, AERO 200, AERO 300, AERO 10S, AERO 20S, AERO100S, AERO 200S, AERO 300S,
GA300S, GA300, GA280S, GA280, GA260S, GA260, GA200S, GA200, GA100S, GA100, GA80S, GA80, GA60S,
AERO S5, AERO GP5, AERO P5, AERO P5R, AERO 5, AERO 5R, CELE H7, CELE H5, CELE H3, CELE H1, CELE L7,
GA1200, GA1280, GA2400, GA2480 Perturbation Training Board
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device