Catalog Number

-

Brand Name

Electrodes

Version/Model Number

PR3827

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2017

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

-

Product Code

NGX

Product Code Name

STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Public Device Record Key

e5f91f95-f817-4a55-b28a-b74a9b937deb

Public Version Date

July 07, 2021

Public Version Number

5

DI Record Publish Date

August 24, 2016

Package DI Number

20075020052074

Quantity per Package

10

Contains DI Package

00075020052988

Package Discontinue Date

December 01, 2017

Package Status

Not in Commercial Distribution

Package Type

-