Catalog Number

EM200S

Brand Name

EMYO®

Version/Model Number

EMYO® 200S

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

-

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

9250c8d3-e005-4d9d-a320-dd40ab4ef16e

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-