Catalog Number

-

Brand Name

HealthmateForever

Version/Model Number

HM8ML Black

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)

-

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

9fec1341-6b26-43e4-9d77-1053e6f73550

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

October 11, 2016

Package DI Number

10817856020086

Quantity per Package

72

Contains DI Package

00817856020089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-