Catalog Number

-

Brand Name

TENS PROS

Version/Model Number

WW8000-TP

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

-

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

19358a2a-e383-4ebb-91b0-ee1956e10351

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2016

Package DI Number

80092237617508

Quantity per Package

500

Contains DI Package

00092237617502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA