Catalog Number

EMS-5000

Brand Name

GEM-STIM

Version/Model Number

EMS-5000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

6b8b42c1-4291-46d6-86d1-61e7340ab7ec

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 23, 2016

Package DI Number

24712832960307

Quantity per Package

30

Contains DI Package

04712832960303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton