DEVICE: Migun (B556HY7000U0)
Device Identifier (DI) Information
Migun
HY7000U
In Commercial Distribution
MIGUN LIFE CO., LTD
HY7000U
In Commercial Distribution
MIGUN LIFE CO., LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35147 | Musculoskeletal infrared phototherapy unit, non-wearable |
An electrically-powered device intended for use in the home or clinical setting 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.
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Active | false |
46083 | Traction table, line-powered |
A 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.
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Active | false |
35538 | Freestanding electric massager |
An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JFB | Table, Physical Therapy, Multi Function |
ISA | Massager, Therapeutic, Electric |
ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K041200 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
db4eae9d-68f7-4892-a656-7092e78a20e6
April 18, 2025
8
May 01, 2017
April 18, 2025
8
May 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined