WalkAnalyst Software Kit - Software used by the clinician to interface with - INNOVATIVE NEUROTRONICS, INC.

Duns Number:791468734

Device Description: Software used by the clinician to interface with the WalkAide unit. This allows data colle Software used by the clinician to interface with the WalkAide unit. This allows data collection,analysis and parameter modification in order to correctly time the applied stimulation to theuser.

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More Product Details

Catalog Number

-

Brand Name

WalkAnalyst Software Kit

Version/Model Number

20-0603

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K140886

Product Code Details

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Device Record Status

Public Device Record Key

3f184751-8a04-4b5a-84ae-d6c6186c9530

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATIVE NEUROTRONICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10