Duns Number:689266158
Device Description: Migun HY7000U is a multi function physio therapy table used primarily for pain relief and 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.
Catalog Number
-
Brand Name
Migun
Version/Model Number
HY7000U
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
K041200
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
db4eae9d-68f7-4892-a656-7092e78a20e6
Public Version Date
April 28, 2022
Public Version Number
6
DI Record Publish Date
May 01, 2017
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 |