Duns Number:054318779
Device Description: Omron TENS Total Power + Heat is a portable, battery-operated device that is designed to r Omron TENS Total Power + Heat is a portable, battery-operated device that is designed to relieve muscle and joint pain.
Catalog Number
PM800CAN
Brand Name
Omron TENS Total Power + Heat for Canada
Version/Model Number
PM800CAN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
9147df99-7c44-47b6-8ae6-0db0ba873b06
Public Version Date
January 23, 2020
Public Version Number
1
DI Record Publish Date
January 15, 2020
Package DI Number
10073796800311
Quantity per Package
12
Contains DI Package
00073796800314
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 |