FDA.reportPublic FDA data

Migun

Primary DI
B344ED3010
Brand
Migun
Company
MIGUN LIFE INC
Model
ED301
Device description
The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is indicated for temporary relief if minor muscle and joint pain, the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain, muscle relaxation therapy and temporary increase of circulation where applied.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B344ED3010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033919008
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B344HY7000U0MigunHY7000U2017-02-11
B344HY7000UM0MigunHY7000UM2016-09-19
B344HY7770MigunHY7772016-09-22
B344MG31000MigunMG31002016-09-22
B344MG33000MigunMG33002016-09-22
B344MG36000MigunMG36002016-09-22

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