Duns Number:054318779
Device Description: Electrotherapy Pain Relief TENS Unit
Catalog Number
PM3031CAN
Brand Name
Omron Pain Relief Pro
Version/Model Number
PM3031CAN
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110068,K110068
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
138ca0c8-7479-45f6-bcc1-94ad34e650ee
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
May 17, 2017
Package DI Number
10073796633148
Quantity per Package
6
Contains DI Package
00073796633141
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 |