Catalog Number

-

Brand Name

Easy@Home Mini Wireless TENS Pulse Stimulator

Version/Model Number

EHE015B

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

K143268,K143268

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

5ad02fa6-9f89-4c68-afab-539b0d9f0992

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Package DI Number

10810038633357

Quantity per Package

80

Contains DI Package

00810038633350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-