FDA.reportPublic FDA data

Migun

Primary DI
B344HY7770
Brand
Migun
Company
MIGUN LIFE INC
Model
HY777
Device description
Far Infra Red photo therapy unit indicated for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual massage, and is approved for relief of muscle and joint pain and stiffness, muscle relaxation, temporary increase in circulation and for temporary arthritis pain relief.
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041200000THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000Migun Medical Instrument Co. , Ltd.2004-06-17JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B344HY7770PrimaryHIBCC0

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B344ED3010MigunED3012016-09-22
B344HY7000U0MigunHY7000U2017-02-11
B344HY7000UM0MigunHY7000UM2016-09-19
B344MG31000MigunMG31002016-09-22
B344MG33000MigunMG33002016-09-22
B344MG36000MigunMG36002016-09-22

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Primary DI, Brand, Company table
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