DEVICE: Migun (B556HY7000UM0)

Device Identifier (DI) Information

Migun
HY7000UM
In Commercial Distribution

MIGUN LIFE CO., LTD
B556HY7000UM0
HIBCC

1
689266158 *Terms of Use
Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
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No

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?
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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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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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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FDA Product Code

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Product Code Product Code Name
ISA Massager, Therapeutic, Electric
ILY Lamp, Infrared, Therapeutic Heating
JFB Table, Physical Therapy, Multi Function
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041200 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4c86023a-e366-4573-922b-818fd84b1f5f
April 18, 2025
8
May 01, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
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Customer Contact

[?]
828-684-1800
migunlife@gmail.com
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