Catalog Number

-

Brand Name

Myotrac 4000 60Hz Unit PP

Version/Model Number

SA4000P

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

K881416

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

f8030001-b8ae-4769-886e-d9a8163fad26

Public Version Date

November 20, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-