Duns Number:053824652
Device Description: Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns o Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
Catalog Number
-
Brand Name
Myotrode One With Gel
Version/Model Number
4060
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040400
Product Code
NUW
Product Code Name
Stimulator, Muscle, Powered, Dental
Public Device Record Key
a6c66e46-e5a6-4299-8740-8d15c0d55718
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 19, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |