FDA.reportPublic FDA data

Comfyhealth

Primary DI
04719879646634
Brand
Comfyhealth
Company
Comfy Health Group Co., Ltd.
Model
BP62
Device description
BRACOO BP62 Low Back Essential moderate joint stablization Gray XL-size
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04719879646634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879646634047198796466344719879646634

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.

Regulatory Flags#

DUNS number
658202517
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719879646610ComfyhealthBP622026-10-28
04719879646627ComfyhealthBP622026-10-28
04719879646658ComfyhealthTP352026-10-28
04719879646672ComfyhealthWB322026-10-28
04719879646696ComfyhealthWS302026-10-28
04719879646603ComfyhealthTP342025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719879646610ComfyhealthComfy Health Group Co., Ltd.ISR2026-10-28
04719879646627ComfyhealthComfy Health Group Co., Ltd.ISR2026-10-28
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00843776102888Neotech CareNEOTECH CARE INC.ISR2026-07-22