Duns Number:526951168
Device Description: TENS stands for Transcutaneous Electrical Nerve Stimulation. The NDGen TENS system is use TENS stands for Transcutaneous Electrical Nerve Stimulation. The NDGen TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.MIC stands for Microcurrent Stimulation. The NDGen MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.IF stands for Interferential Stimulation. The NDGen IF system is indicated for:• Symptomatic relief of chronic intractable pain.
Catalog Number
-
Brand Name
NDGen
Version/Model Number
NDGen
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
dfd18029-4212-4fff-999e-3ce9fa6a9c15
Public Version Date
November 23, 2021
Public Version Number
1
DI Record Publish Date
November 15, 2021
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. | 25 |