Catalog Number

-

Brand Name

7E Wellness

Version/Model Number

Myocalme RC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090052

Product Code

QJQ

Product Code Name

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Public Device Record Key

f6753cc0-ed2d-49fd-89eb-c202bb14629d

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

April 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-