Catalog Number

-

Brand Name

iSelfCare

Version/Model Number

HM24AB 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

d2294fa9-26cc-4ea5-b153-5808202fcd2c

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 06, 2019

Package DI Number

10817856020758

Quantity per Package

72

Contains DI Package

00817856020751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-