Catalog Number

-

Brand Name

Essential TENS System

Version/Model Number

S1000

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

745d53f3-c109-477b-8d7a-5e5ac19dedb3

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

April 11, 2017

Package DI Number

10754756740006

Quantity per Package

30

Contains DI Package

00754756740009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-