Catalog Number

-

Brand Name

ETEKCITY TENS Unit Electrode Pads(50x50mm)

Version/Model Number

ETU-P12

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

K141076,K141076,K141076

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

e5bf8c8f-9635-4f6d-a102-56d7a5eaf52e

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

September 20, 2019

Package DI Number

20817915020047

Quantity per Package

40

Contains DI Package

10817915020040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton