COMFY HEALTH GROUP CO., LTD.

FDA Device Registration & Listing · Taipei, TW · Registration 3014690514

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014690514
FEI Number
3014690514
Entity Name
COMFY HEALTH GROUP CO., LTD.
City/State/Country
Taipei, TW
Establishment Address
No 26, Aly 9, Ln 181, Jiaxing St., Taipei 110006, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Comfy Health Group Co., Ltd. (Owner Number: 10083990)
Owner / Operator Contact Address
No 26, Aly 9, Ln 181, Jiaxing St., Taipei, TW-TPE 110006, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray XL-size 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 FP30 Ankle Fulcrum wrap Black S/M KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey XL-Size KS10 Knee Fulcrum Wrap Comfort fit Black KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size FE90 Foot Arch Airy Sleeve Airy & Comfysoft M-size Pair KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray L-size KS10 Knee Fulcrum Wrap Comfort Fit Gray FP30 Ankle Fulcrum wrap Black L/XL KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey M-Size Pair FE90 Foot Arch Airy Sleeve Airy & Comfysoft S-size Pair KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray M-size 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 KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey XL-Size Pair KB30 Knee Fulcrum Wrap Dual Splints Stablizer w/Fixation Pad KP40 Knee Patella Fulcrum Wrap Easyfit w/Cushion Tube KP30 Knee Fulcrum Wrap Ergonomic Stabilizer 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 KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray S-size KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey S-Size Pair FS60 Ankle Airy Sleeve Breathable & 4-way stretch w/ Wrap Gray S/M-size FS10 Ankle Fulcrum Wrap Comfort fit Pink S/M KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey L-Size Pair 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 KS10 Knee Fulcrum Wrap Comfort fit Pink KP31 Knee Fulcrum Wrap Sponged Ergo Stabilizer 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2022-01-06
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2022-01-06
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2022-01-06
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2022-01-06
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2022-01-06
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2022-01-06

Official Correspondent

Joe Kuo

US Agent Details

Joe kuo Business: Comfytopia lnc. Email: bracoo.tw@gmail.com Phone: (510) 3600090

Related Public Records

Same Entity

Comfy Health Group Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014690514. Last updated year: 2026. Please use registration number 3014690514 when referencing this establishment in official correspondence.
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