Duns Number:054318779
Device Description: Omron TENS Gel Refills are to be used with the OMRON TENS devices with heat.
Catalog Number
PMGELCAN
Brand Name
Omron TENS Gel Refill
Version/Model Number
PMGELCAN
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181992,K181992,K181992
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
60b347ab-cd31-49f1-9dcd-99a8641a1c8f
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 08, 2020
Package DI Number
20073796752310
Quantity per Package
6
Contains DI Package
10073796752313
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |