Catalog Number

D2-D5-D5

Brand Name

SERIES-5 MyoVision FlexVision System

Version/Model Number

D2-D5

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

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

d71c09e8-999d-4408-b3c4-087294c0f868

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-