Catalog Number

-

Brand Name

Easy@Home Electronic TENS Pulse Massager

Version/Model Number

EHE012PRO

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

K131921,K131921

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

ba582ea8-4fe3-40c6-9467-e3ccf0f71caa

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

10810038630103

Quantity per Package

20

Contains DI Package

00810038630106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton