Catalog Number

A10002

Brand Name

NTrainer

Version/Model Number

A10002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

1cf4074f-9a99-4b3a-90b9-24c3be61473c

Public Version Date

January 15, 2019

Public Version Number

1

DI Record Publish Date

December 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-