MyndMove - MyndTec Inc

Duns Number:203019245

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More Product Details

Catalog Number

920276

Brand Name

MyndMove

Version/Model Number

MyndMove Mobile Cart

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K170564,K212149

Product Code Details

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Device Record Status

Public Device Record Key

9473c86d-fd78-456e-823a-c3d97fd554cd

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MYNDTEC INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 51