DEVICE: Migun (B344MG36000)

Device Identifier (DI) Information

Migun
MG3600
In Commercial Distribution

MIGUN LIFE INC
B344MG36000
HIBCC

1
033919008 *Terms of Use
The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is indicated for temporary relief if minor muscle and joint pain, the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain, muscle relaxation therapy and temporary increase of circulation where applied.
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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
IRT Pad, Heating, Powered
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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

9e0567bc-cb13-460e-a1e2-5727bfcc65a8
June 19, 2018
4
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
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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
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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