Catalog Number

-

Brand Name

Easy@Home Mini Electronic Pulse Stimulator

Version/Model Number

EHE029G

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

K141260,K141260

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

dc8f9efc-f284-42c5-846c-046499161a72

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

10810038630165

Quantity per Package

20

Contains DI Package

00810038630168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton