FDA.reportPublic FDA data

Migun

Primary DI
B556HY7000U0
Brand
Migun
Company
MIGUN LIFE CO., LTD
Model
HY7000U
Device description
Migun HY7000U is a multi function physio therapy table used primarily for pain relief and to increase local circulation. It utilizes thermal far infrared therapeutic heating, therapeutic manual massage and electric massage. Indicated for muscle and joint pain and stiffness, muscle relaxation temporary increase in circulation and for temporary arthritis pain relief.
Published
2017-05-01
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
ISAMassager, Therapeutic, Electric
JFBTable, Physical Therapy, Multi Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
JFBTable, Physical Therapy, Multi FunctionPhysical 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
B556HY7000U0PrimaryHIBCC0

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
689266158
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B556ED3010MigunED3012017-05-01
B556HY7000UM0MigunHY7000UM2017-05-01
B556HY7770MigunHY7772017-05-01
B556MG31000MigunMG31002017-05-01
B556MG33000MigunMG33002017-05-01
B556MG36000MigunMG36002017-05-01

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