Catalog Number

PM3032CAN

Brand Name

Omron Max Power Relief

Version/Model Number

PM3032CAN

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

K141978,K141978

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

ae5c2dca-15ed-461e-86de-662681107fb9

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

10073796303232

Quantity per Package

6

Contains DI Package

00073796303235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case