Catalog Number

-

Brand Name

COMPEX

Version/Model Number

506011TENS

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

ef014c16-adbe-425b-9a74-ed32b8d68083

Public Version Date

December 29, 2021

Public Version Number

7

DI Record Publish Date

November 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-