Catalog Number

-

Brand Name

Easy@Home Adhesive Electrodes

Version/Model Number

ETP505

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

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

eb7a8d96-8e7c-4def-9ded-c5370e555374

Public Version Date

February 11, 2020

Public Version Number

1

DI Record Publish Date

February 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-