Catalog Number

-

Brand Name

Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads

Version/Model Number

ETP015

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,K141260

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

d97d5f3f-49c4-4e6b-9db9-75dc2ae4a27c

Public Version Date

August 08, 2019

Public Version Number

1

DI Record Publish Date

July 31, 2019

Package DI Number

10855944007656

Quantity per Package

30

Contains DI Package

00855944007659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton