Catalog Number

-

Brand Name

NeuroMove

Version/Model Number

400275

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

K012885

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

b81fd52c-9474-48cd-900e-3fc3db65646d

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-