Duns Number:033919008
Device Description: The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is in 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.
Catalog Number
-
Brand Name
Migun
Version/Model Number
MG3300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
5b85d093-6d7e-4516-8d7f-8c59c8dd6714
Public Version Date
June 19, 2018
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |