FDA Registration
Active
🇹🇼 Taiwan
FP30 Ankle Fulcrum wrap Black S/M
Reg #: 3014690514
·
FEI: 3014690514
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COMFY HEALTH GROUP CO., LTD.
- Registration Number
- 3014690514
- FEI Number
- 3014690514
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 26, Aly 9, Ln 181, Jiaxing St.
- City
- Taipei
- Country
- TW
Owner / Operator
- Firm Name
- Comfy Health Group Co., Ltd.
- Operator Number
- 10083990
- Address
- No 26, Aly 9, Ln 181, Jiaxing St.
- City
- Taipei
- State
- TW-TPE
- Postal Code
- 110006
- Country
- TW
- Correspondent
- Joe Kuo
US Agent
- Business Name
- Comfytopia lnc.
- Contact Name
- Joe kuo
- Address
- 47000 Warm Springs Blvd., Suite 1-257
- City
- Fremont
- State
- CA
- ZIP
- 94539
- Country
- US
- [email protected]
- Phone
- 510 3600090
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2022-01-06 |
Proprietary Names
FP30 Ankle Fulcrum wrap Black S/M
FS10 Ankle Fulcrum Wrap Comfort fit Pink L/XL
FP30 Ankle Fulcrum wrap Black L/XL
FP31 Ankle Fulcrum Pro WrapErgo Splint & StabilizerBlack S/M
FS10 Ankle Fulcrum Wrap Comfort fit Black L/XL
FS10 Ankle Fulcrum Wrap Comfort fit Black S/M
FS10 Ankle Fulcrum Wrap Comfort fit Gray S/M
FS10 Ankle Fulcrum Wrap Comfort fit Gray L/XL
FS10 Ankle Fulcrum Wrap Comfort fit Pink S/M
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device