Duns Number:053824652
Device Description: The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxe The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
Catalog Number
4450
Brand Name
J5 Myo-Monitor
Version/Model Number
J5
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUW
Product Code Name
Stimulator, Muscle, Powered, Dental
Public Device Record Key
4222f095-2309-4dfa-a0b0-4feda0a4363b
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
August 18, 2016
Package DI Number
D7924450C0
Quantity per Package
1
Contains DI Package
D79244500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cased Unit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |