Duns Number:054318779
Device Description: Replacement Pad for Focus Knee TENS . The pad is a disposable, conductive adhesive interf Replacement Pad for Focus Knee TENS . The pad is a disposable, conductive adhesive interface and should only be used with the Focus Knee TENS devices.
Catalog Number
PMKNPAD
Brand Name
Omron Focus TENS Knee, Replacement Pad
Version/Model Number
PMKNPAD
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
K183215,K183215,K183215
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
cd960748-16f4-45f2-80ba-a79e307ec411
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 15, 2020
Package DI Number
02007379663162
Quantity per Package
4
Contains DI Package
10073796631465
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 |