FDA.reportPublic FDA data

Comfyhealth

Primary DI
04719879646603
Brand
Comfyhealth
Company
Comfy Health Group Co., Ltd.
Model
TP34
Device description
BRACOO TP34 Thumb Fulcrum Wrap Ergonomic Splint Black Free size
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISRBand Or Belt, Pelvic Support

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719879646603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879646603047198796466034719879646603

GMDN Terms#

Term, Definition table
TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658202517
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719879641868ComfyHealthSE232025-07-10
04719879641875ComfyHealthSE232025-07-10
04719879642889ComfyHealthFP312025-07-10
04719879644562ComfyHealthBP612025-07-10
04719879646009ComfyHealthKP322025-07-10
04719879646108ComfyHealthEE922025-07-10
04719879646115ComfyHealthEE922025-07-10
04719879646122ComfyHealthEE922025-07-10
04719879646139ComfyHealthEE922025-07-10
04719879646146ComfyHealth EE922025-07-10
04719879646153ComfyHealthEE922025-07-10
04719879646160ComfyHealthEE922025-07-10
04719879646177ComfyHealthEE922025-07-10
04719879646566ComfyHealthTB502025-07-10
04719879646580ComfyHealthWB512025-07-10
04719879641011ComfyHealthWP402023-12-05
04719879644661ComfyHealthEP422023-12-05
04719879644678ComfyHealthEP422023-12-05
04719879644685ComfyHealthEP422023-12-05
04719879644692ComfyHealthEP422023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113683416Three in One Belly BandManamed, Inc.ISR2025-11-25
04719879641868ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879641875ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879644562ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
00819567011233ComfytopiaComfytopia, Inc.ISR2025-07-09
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
00810113579122ViveVIVE HEALTH LLCISR2025-05-20
00810113579139ViveVIVE HEALTH LLCISR2025-05-20
00810113579146ViveVIVE HEALTH LLCISR2025-05-20
00810113579153ViveVIVE HEALTH LLCISR2025-05-20
10810113579129ViveVIVE HEALTH LLCISR2025-05-20
10810113579136ViveVIVE HEALTH LLCISR2025-05-20
10810113579143ViveVIVE HEALTH LLCISR2025-05-20
10810113579150ViveVIVE HEALTH LLCISR2025-05-20
05061035460530Love NoobsROBUST VENTURES LTDISR2025-02-21
00810041981158CoreTechVIVE HEALTH LLCISR2024-09-06
10810041981155CoreTechVIVE HEALTH LLCISR2024-09-06
06973712280043AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
06973712280050AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
10326053118514Regard™Resource Optimization & Innovation, L.L.C.ISR2023-08-10
20326053118511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.ISR2023-08-10
00840252901881Therafit BeltsTherafin CorporationISR2023-07-06
00840252901898Therafit BeltsTherafin CorporationISR2023-07-06
00840252901904Therafit BeltsTherafin CorporationISR2023-07-06
00840252902062Therafit BeltsTherafin CorporationISR2023-07-06
00840252902079Therafit BeltsTherafin CorporationISR2023-07-06
00840252902086Therafit BeltsTherafin CorporationISR2023-07-06
00840252902093Therafit BeltsTherafin CorporationISR2023-07-06
00840252902116Therafit BeltsTherafin CorporationISR2023-07-06
10810041980295CoreTechVIVE HEALTH LLCISR2023-06-15