ComfyHealth

Primary DI
04719879646009
Brand
ComfyHealth
Company
Comfy Health Group Co., Ltd.
Model
KP32
Device description
BRACOO KP32 Knee Airy Wrap Breathable & Ergo Cushion Pad
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
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719879646009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879646009047198796460094719879646009

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-joint lower limb orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the lower body which will include the knee (e.g., hip and knee, knee and ankle). The device is typically adjustable and articulating. 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
04719879641868ComfyHealthSE232025-07-10
04719879641875ComfyHealthSE232025-07-10
04719879642889ComfyHealthFP312025-07-10
04719879644562ComfyHealthBP612025-07-10
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

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Primary DI, Brand, Company table
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00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
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00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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