Catalog Number

-

Brand Name

DynaVision Dynamic sEMG Electrodes

Version/Model Number

PB-50

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

K123399,K123399,K123399,K123399

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

fc198a70-0720-4eca-9375-4941d8a91ce3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2016

Package DI Number

10853818007122

Quantity per Package

5

Contains DI Package

00853818007125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch