Catalog Number

PM3030

Brand Name

Omron Electrotherapy Pain Relief

Version/Model Number

PM3030

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

K110068,K110068

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

0a40c9c9-12d7-4a38-846b-ccab1bca6099

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

10073796633032

Quantity per Package

12

Contains DI Package

00073796633035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case