Catalog Number

-

Brand Name

Easy@Home Self-Adhesive Reusable Electrodes

Version/Model Number

ETP101

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

K132588,K132588,K132588

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

8d9feb26-d6a7-46f8-bb5c-731d52c4128d

Public Version Date

November 26, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

10850253007786

Quantity per Package

96

Contains DI Package

00850253007789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton