Duns Number:054318779
Device Description: Electrotherapy Heat Pain Pro TENS Unit
Catalog Number
PM311
Brand Name
Omron Heat Pain Pro
Version/Model Number
PM311
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
K160115,K160115,K160115
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
33af2159-f1df-49a9-9e79-b7cc68127834
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
May 17, 2017
Package DI Number
10073796633117
Quantity per Package
6
Contains DI Package
00073796633110
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 |