FDA Registration
Active
🇹🇼 Taiwan
TB50 Finger Armor wrap 3D Ergo Fixation & Breathable
Reg #: 3014690514
·
FEI: 3014690514
·
Expires 2025
Products
1
Proprietary Names
23
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 |
|---|---|---|---|---|---|
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2022-01-06 |
Proprietary Names
TB50 Finger Armor wrap 3D Ergo Fixation & Breathable
TP33 Thumb Fulcrum wrap Ergonomic Stabilizer
ES10 Elbow Fulcrum Wrap Comfort fit Gary
EP41 Tennis Elbow Fulcrum Pro Wrap 3D Ergo EVA Pad
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayL-size Pair
WB30 Wrist Fulcrum Wrap Orth Ergo Cushion Splint
WS10 Wrist Fulcrum Wrap Easy fit Pink
EP30 Elbow Fulcrum Wrap Ergonomic Splint
WS10 Wrist Fulcrum Wrap Easy fit Black
ES10 Elbow Fulcrum Wrap Comfort fit Black
WB50 Wrist Armor Wrap 3D Ergo Fixation & Breathable L/XL size
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayM-size Pair
WS11 Wrist Fulcrum Wrap Easyfit w/Splint
TP30 Thumb Fulcrum Wrap Ergonomic Splint
TP32 Thumb Fulcrum wrap Ergonomic Stabilizer
WS10 Wrist Fulcrum Wrap Easy fit Gray
WB31 Wrist Fulcrum Wrap Orth Ergo Cushion Splint
WB50 Wrist Armor Wrap 3D Ergo Fixation & Breathable S/M size
EP40 Tennis Elbow Fulcrum Wrap Easy fit w/Cushion PadGray
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayS-size Pair
WP30 Wrist Fulcrum Wrap Ergonomic Cushion Splint
ES10 Elbow Fulcrum Wrap Comfort fit Pink
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayXL-size Pair
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device