Catalog Number

A00002

Brand Name

NTrainer

Version/Model Number

A00002

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

K071866

Product Code

HCC

Product Code Name

Device, biofeedback

Public Device Record Key

4199cf55-5e14-4959-97ed-1fea374c2866

Public Version Date

February 26, 2020

Public Version Number

1

DI Record Publish Date

February 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-