FDA.reportPublic FDA data

Migun

Primary DI
B556HY7000UM0
Brand
Migun
Company
MIGUN LIFE CO., LTD
Model
HY7000UM
Device description
Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
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
B556HY7000UM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy massagerA mains electricity (AC-powered) device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
828-684-1800migunlife@gmail.com

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
B556HY7000U0MigunHY7000U2017-05-01
B556HY7770MigunHY7772017-05-01
B556MG31000MigunMG31002017-05-01
B556MG33000MigunMG33002017-05-01
B556MG36000MigunMG36002017-05-01

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