DEVICE: Migun (B344HY7770)

Device Identifier (DI) Information

Migun
HY777
In Commercial Distribution

MIGUN LIFE INC
B344HY7770
HIBCC

1
033919008 *Terms of Use
Far Infra Red photo therapy unit indicated for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Musculoskeletal infrared phototherapy unit, non-wearable A 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.
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FDA Product Code

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Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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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

86758976-5609-4bc6-a1e2-a7623aa41c58
May 08, 2018
3
September 22, 2016
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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
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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