Migun

Primary DI
B344HY7000UM0
Brand
Migun
Company
MIGUN LIFE INC
Model
HY7000UM
Device description
Migun HY7000UM is a multi-function physio therapy table used primarily for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual and electric 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
2016-09-19
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
B344HY7000UM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Traction table, line-poweredA mobile, mains electricity (AC-powered) table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient?s spine, or apply a rotational roller mechanism protruding through the table surface to the spine, or employ masts and traction accessories for lumbar and cervical traction in a sitting position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is used in a healthcare facility.

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
B344HY7770MigunHY7772016-09-22
B344MG31000MigunMG31002016-09-22
B344MG33000MigunMG33002016-09-22
B344MG36000MigunMG36002016-09-22

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