Catalog Number

PM601

Brand Name

Omron Avail Wireless T.E.N.S.

Version/Model Number

PM601

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

K172079,K172079

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

8f6e0e31-2852-423b-afb2-76a60c9fdeb5

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

December 15, 2017

Package DI Number

10073796636019

Quantity per Package

6

Contains DI Package

00073796636012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case