Catalog Number

KIMD7

Brand Name

Impulse EMS D7

Version/Model Number

D7

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2017

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

K063642

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

51818cef-69ad-4419-a32b-dc6bf22a6d44

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-