Duns Number:054318779
Device Description: Omron TENS Therapy Unit with Heat and 9 preset mode, 2 therapy choices and 20 intensity le Omron TENS Therapy Unit with Heat and 9 preset mode, 2 therapy choices and 20 intensity levels.
Catalog Number
PM800
Brand Name
Omron Total Power + Heat TENS Unit
Version/Model Number
PM800
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
K181992,K181992,K181992
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
e4fb52f3-0ebc-46fc-b7c6-e523b376b720
Public Version Date
November 07, 2019
Public Version Number
3
DI Record Publish Date
May 06, 2019
Package DI Number
10073796638006
Quantity per Package
12
Contains DI Package
00073796638009
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 |