Catalog Number

ES-160

Brand Name

ES-160

Version/Model Number

ES-160

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051020,K051020

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

947bf6ee-f48b-4ed2-a4aa-a2d9d9404727

Public Version Date

December 07, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

24983087008490

Quantity per Package

5

Contains DI Package

04983087008496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-