Catalog Number

900122

Brand Name

MyndMove

Version/Model Number

MyndMove Electrode Cable Blue

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K170564,K170564

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Public Device Record Key

80a2a79c-ceea-45a1-9bf3-16dc5d6447bd

Public Version Date

December 19, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-