Catalog Number

-

Brand Name

Easy@Home Heat TENS unit with Replacement Pads

Version/Model Number

ETP018

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

K200561,K200561,K200561

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

d63ae50b-a010-4153-940f-cd692dcb6abf

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

10810038631544

Quantity per Package

400

Contains DI Package

00810038631547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-