Catalog Number

KEMS

Brand Name

EMS2000

Version/Model Number

EMS2000

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

K884651,K884651

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

b3af4cf4-5ec8-46b6-ae35-d9c6b215cfc8

Public Version Date

February 19, 2021

Public Version Number

9

DI Record Publish Date

September 23, 2016

Package DI Number

10857771003177

Quantity per Package

60

Contains DI Package

00857771003170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case