FDA Registration
Active
🇹🇼 Taiwan
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey L-Size Pair
Reg #: 3014690514
·
FEI: 3014690514
·
Expires 2025
Products
1
Proprietary Names
38
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, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2022-01-06 |
Proprietary Names
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey L-Size Pair
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey S-Size
FP30 Ankle Fulcrum wrap Black S/M
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey S-Size Pair
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey M-Size Pair
FS10 Ankle Fulcrum Wrap Comfort fit Pink S/M
KP31 Knee Fulcrum Wrap Sponged Ergo Stabilizer
KP32 Knee Airy Wrap Breathable & Ergo Cushion Pad
FS10 Ankle Fulcrum Wrap Comfort Fit Gray S/M
FS10 Ankle Fulcrum Wrap Comfort Fit Black L/XL
FE90 Foot Arch Airy Sleeve Airy & Comfysoft L-size Pair
FE90 Foot Arch Airy Sleeve Airy & Comfysoft M-size Pair
FS10 Ankle Fulcrum Wrap Comfort Fit Black S/M
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Black L/XL-size
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Black S/M-size
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey M-Size
LE70 Calf Fulcrum Sleeve Comfort Fit Black L/XL-size Pair
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Gray S/M-size
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray L-size
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size
KS10 Knee Fulcrum Wrap Comfort fit Pink
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Gray L/XL--size
FP30 Ankle Fulcrum wrap Black L/XL
FE90 Foot Arch Airy Sleeve Airy & Comfysoft S-size Pair
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey XL-Size Pair
FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black S/M
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray M-size
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray S-size
KP40 Knee Patella Fulcrum Wrap Easyfit w/Cushion Tube
KP30 Knee Fulcrum Wrap Ergonomic Stabilizer
FS10 Ankle Fulcrum Wrap Comfort Fit Pink L/XL
KS10 Knee Fulcrum Wrap Comfort Fit Gray
LE70 Calf Fulcrum Sleeve Comfort Fit Black S/M-size Pair
KB30 Knee Fulcrum Wrap Dual Splints Stablizer w/Fixation Pad
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey XL-Size
FS10 Ankle Fulcrum Wrap Comfort Fit Gray L/XL
KS10 Knee Fulcrum Wrap Comfort fit Black
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray XL-size
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device