Duns Number:504712829
Device Description: The SMART TENS is used for the symptomatic relief and management of chronic intractable pa The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Catalog Number
-
Brand Name
Smart TENS
Version/Model Number
TN-SMARTTENS
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
K091045
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
d718595e-8199-4df4-b990-32fb103848a6
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
February 12, 2017
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. | 9 |