FDA Registration
Active
🇹🇼 Taiwan
COMFY HEALTH GROUP CO., LTD.
Reg #: 3014690514
·
FEI: 3014690514
·
Expires 2026
Products
8
Proprietary Names
123
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- COMFY HEALTH GROUP CO., LTD.
- Registration Number
- 3014690514
- FEI Number
- 3014690514
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2022-01-06 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2022-01-06 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2022-01-06 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2022-01-06 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2022-01-06 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2022-01-06 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2022-01-06 |
Proprietary Names
WB30 Wrist Fulcrum Wrap Orth Ergo Cushion Splint
WS10 Wrist Fulcrum Wrap Easy fit Black
WP30 Wrist Fulcrum Wrap Ergonomic Cushion Splint
TP33 Thumb Fulcrum wrap Ergonomic Stabilizer
TB50 Finger Armor wrap 3D Ergo Fixation & Breathable
WB50 Wrist Armor Wrap 3D Ergo Fixation & Breathable S/M size
ES10 Elbow Fulcrum Wrap Comfort fit Pink
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayL-size Pair
EP30 Elbow Fulcrum Wrap Ergonomic Splint
WB50 Wrist Armor Wrap 3D Ergo Fixation & Breathable L/XL size
TP32 Thumb Fulcrum wrap Ergonomic Stabilizer
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayS-size Pair
EP40 Tennis Elbow Fulcrum Wrap Easy fit w/Cushion PadGray
EP41 Tennis Elbow Fulcrum Pro Wrap 3D Ergo EVA Pad
WS10 Wrist Fulcrum Wrap Easy fit Gray
WB31 Wrist Fulcrum Wrap Orth Ergo Cushion Splint
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayM-size Pair
TP30 Thumb Fulcrum Wrap Ergonomic Splint
WS10 Wrist Fulcrum Wrap Easy fit Pink
EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayXL-size Pair
WS11 Wrist Fulcrum Wrap Easyfit w/Splint
ES10 Elbow Fulcrum Wrap Comfort fit Black
ES10 Elbow Fulcrum Wrap Comfort fit Gary
KE60 Knee Airy Sleeve Breathable & Stabilize Gray M-size Pair
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey S-Size Pair
KE60 Knee Airy Sleeve Breathable & Stabilize BlackXL-size
KE60 Knee Airy Sleeve Breathable & Stabilize Gray L-size Pair
KE60 Knee Airy Sleeve Breathable & Stabilize Black S-size
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey S-Size Pair
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray M-size
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey XL-Size Pair
KS10 Knee Fulcrum Wrap Comfort fit Black
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray S-size
KS10 Knee Fulcrum Wrap Comfort fit Gray
KP30 Knee Fulcrum Wrap Ergonomic Stabilizer
KB30 Knee Fulcrum Wrap Dual Splints Stablizer w/Fixation Pad
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray L-size
KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray XL-size
KE60 Knee Airy Sleeve Breathable & Stabilize Black L-size
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey M-Size Pair
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey M-Size Pair
KE60 Knee Airy Sleeve Breathable & Stabilize Gray XL-size Pair
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size Pair
KS10 Knee Fulcrum Wrap Comfort fit Pink
KP31 Knee Fulcrum Wrap Sponged Ergo Stabilizer
KE60 Knee Airy Sleeve Breathable & Stabilize Gray S-size Pair
KP40 Knee Patella Fulcrum Wrap Easyfit w/Cushion Tube
KE60 Knee Airy Sleeve Breathable & Stabilize Black M-size
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey L-Size Pair
KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey XL-Size Pair
HB5MW0-C110 CHAIR AND TABEL, MEDICAL
FS10 Ankle Fulcrum Wrap Comfort fit Black S/M
FP30 Ankle Fulcrum wrap Black S/M
FS10 Ankle Fulcrum Wrap Comfort fit Pink S/M
FP30 Ankle Fulcrum wrap Black L/XL
FP31 Ankle Fulcrum Pro WrapErgo Splint & StabilizerBlack S/M
FS10 Ankle Fulcrum Wrap Comfort fit Gray L/XL
FS10 Ankle Fulcrum Wrap Comfort fit Gray S/M
FS10 Ankle Fulcrum Wrap Comfort fit Black L/XL
FS10 Ankle Fulcrum Wrap Comfort fit Pink L/XL
FS10 Ankle Fulcrum Wrap Comfort Fit Gray L/XL
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Black L/XL-size
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Gray L/XL--size
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey XL-Size
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size
FE90 Foot Arch Airy Sleeve Airy & Comfysoft M-size Pair
KS10 Knee Fulcrum Wrap Comfort Fit Gray
FE90 Foot Arch Airy Sleeve Airy & Comfysoft S-size Pair
FE90 Foot Arch Airy Sleeve Airy & Comfysoft L-size Pair
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey M-Size
LE70 Calf Fulcrum Sleeve Comfort Fit Black L/XL-size Pair
KP32 Knee Airy Wrap Breathable & Ergo Cushion Pad
FS10 Ankle Fulcrum Wrap Comfort Fit Black S/M
KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey S-Size
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Black S/M-size
FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Gray S/M-size
LE70 Calf Fulcrum Sleeve Comfort Fit Black S/M-size Pair
FS10 Ankle Fulcrum Wrap Comfort Fit Pink L/XL
FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black S/M
FS10 Ankle Fulcrum Wrap Comfort Fit Gray S/M
FS10 Ankle Fulcrum Wrap Comfort Fit Black L/XL
BP30 Low Back Fulcrum Wrap Ergo stabilizing Splint BlackL-size
BP31 Low Back Fulcrum Wrap Ergo Stabilizing Splint Gray M-size
MS60 Maternity Belt Fulcrum Wrap Comfy & Ultrasoft Beige
BS80 Neck Fulcrum Wrap Breathable Gary
BP30 Low Back Fulcrum Wrap Ergo stabilizing Splint BlackM-size
BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayL-size
BS34 Upper Back Fulcrum Wrap Ergonomic Splint
BS80 Neck Fulcrum Wrap Breathable Black
BP60 Low Back Airy Wrap Airy w/Ergo Splint Black S-size
BP31 Low Back Fulcrum Wrap Ergo Stabilizing Splint Gray S-size
SE20 Waist trimmer wrap Enhancement
MS61 Maternity Belt Fulcrum Wrap Easy Fit & Soft Pink
SE22 Waist trimmer Wrap Comfort Fit Trimmer Black L/XL-size
MS90 Pelvis Belt Fulcrum Wrap Comfy & UltraSoft BeigeS/M-size
BP31 Low Back Fulcrum Wrap Ergo Stabilizing Splint Gray L-size
BB31 Low Back Armor Wrap Airy 3D Fixation DesignBlack S-size
BS30 Low Back Fulcrum Wrap Comfyfit w/Splint Black L/XL
BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayM-size
SE23 Waist Trimmer Wrap Comfort Fit & Wicking Black S/M-size
MS60 Maternity Belt Fulcrum Wrap Comfy & Ultrasoft Black
SE23 Waist Trimmer Wrap Comfort Fit & Wicking Black L/XL-size
BS30 Low Back Fulcrum Wrap Comfyfit w/Splint Black S/M
BP30 Low Back Fulcrum Wrap Ergo stabilizing Splint BlackS-size
BB31 Low Back Armor Wrap Airy 3D Fixation DesignBlack L-size
BP60 Low Back Airy Wrap Airy w/Ergo Splint Black M-size
BB30 Low Back Airy Wrap Orth Ergo Splint Black L-size
MS90 Pelvis Belt Fulcrum Wrap Comfy & UltraSoft BeigeL/XL-size
BB30 Low Back Airy Wrap Orth Ergo Splint Black M-size
SE22 Waist trimmer Wrap Comfort Fit Trimmer Black S/M-size
BB30 Low Back Airy Wrap Orth Ergo Splint Black S-size
BB31 Low Back Armor Wrap Airy 3D Fixation DesignBlack M-size
BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayS-size
BP60 Low Back Airy Wrap Airy w/Ergo Splint Black L-size
BS33 Low Back Fulcrum Wrap Easyfit w/Splint
LE71 Fulcrum Compression Socks Comfort Fit Black S-sizePair
LE71 Fulcrum Compression Socks Comfort Fit Black L-sizePair
LE71 Fulcrum Compression Socks Comfort Fit Black XL-size Pair
LE71 Fulcrum Compression Socks Comfort Fit Black M-size Pair
HM1MB0-C110 CANE
HM1MB1-C110 CANE
HMAM0Y0-C110 CRUTCH
HM1MY0-C110 CANE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device