Duns Number:008513913
Device Description: Two-channel battery-operated TENS unit
Catalog Number
ME 210
Brand Name
TENS 210
Version/Model Number
ME 210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
K002874
Product Code
GZJ
Product Code Name
STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
Public Device Record Key
6272d91e-4988-4009-bb35-ec131d3d07c2
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 57 |