Catalog Number

-

Brand Name

Etekcity TENS Unit

Version/Model Number

ETU-134

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

K130802,K130802

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

0872ae02-dd3c-4fd6-8b96-baf5e6a2a012

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

April 22, 2019

Package DI Number

10817915020019

Quantity per Package

40

Contains DI Package

00817915020012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case