Catalog Number

-

Brand Name

TeleMyo

Version/Model Number

548

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 13, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

f9e7336b-dffb-49a3-b157-9ad5ebcbd321

Public Version Date

November 07, 2019

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-