FDA.reportPublic FDA data

ComfyHealth

Primary DI
04719879641868
Brand
ComfyHealth
Company
Comfy Health Group Co., Ltd.
Model
SE23
Device description
BRACOO SE23 Waist trimmer Wrap Comfort Fit & Wicking Performance Black SIZE:S/M
Published
2025-07-10
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
04719879641868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879641868047198796418684719879641868

GMDN Terms#

Term, Definition table
TermDefinition
Static magnetic orthopaedic orthosisA body-support orthopaedic device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around a body area (e.g., shoulder, elbow, thoracic or lumbar spine region, knee, foot arch) and produce a weak magnetic flux field to assist the whole body’s innate healing capability to alleviate body aches and pains (e.g., from muscle soreness/stiffness, arthritis). 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
04719879646603ComfyhealthTP342025-12-08
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
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