Catalog Number

PMLLPAD

Brand Name

Omron Electrotherapy Pain Relief Long Life Pads

Version/Model Number

PMLLPAD

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

K120516,K120516,K120516,K120516

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

f572c38b-e7af-438f-9c55-a0128008e9cf

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

10073796226142

Quantity per Package

12

Contains DI Package

00073796226145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton