Duns Number:783518983
Device Description: 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens UnitThe life of 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens UnitThe life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following the instructions for use found in the manual. The expired electrodes are to be recycled and do not harm the environment.
Catalog Number
7218
Brand Name
Pro Comfort Tens Unit Pads
Version/Model Number
SM120
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
46ed4c22-ea27-4902-acc2-740b6c993fa6
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
December 01, 2017
Package DI Number
10850632007215
Quantity per Package
160
Contains DI Package
00850632007218
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
out box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |