Duns Number:867673159
Device Description: ElectrotherapyTens Product Description: Digital TENS,Dual Channel,1/bx
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
AGF-5X
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"
-
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
GZJ
Product Code Name
STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
Public Device Record Key
3a1c3171-63c5-4596-8417-06d17fd3ca40
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
July 01, 2016
Package DI Number
50822383104510
Quantity per Package
30
Contains DI Package
00822383104515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |