Catalog Number

910200

Brand Name

MyndMove

Version/Model Number

MyndMove Functional Electrical System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2019

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

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Public Device Record Key

72d8dfda-e392-4ecf-8f3b-a2153970e28f

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

October 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-