Catalog Number

KBSI

Brand Name

BioStim INF

Version/Model Number

INF

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

K040824,K040824

Product Code

LIH

Product Code Name

Interferential Current Therapy

Public Device Record Key

84ed8c87-cec2-42ae-b56f-30a36028a86b

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10857771003214

Quantity per Package

48

Contains DI Package

00857771003217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case