WalkAide 1.25 Premium Electrodes - pkg of 4 - Transcutaneous Electrical Stimulation Electrode - INNOVATIVE NEUROTRONICS, INC.

Duns Number:791468734

Device Description: Transcutaneous Electrical Stimulation Electrode

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More Product Details

Catalog Number

-

Brand Name

WalkAide 1.25 Premium Electrodes - pkg of 4

Version/Model Number

20-0521

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

-

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

298c5a1d-47e0-4217-90f9-5582027dfc95

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 16, 2016

Additional Identifiers

Package DI Number

10858184006106

Quantity per Package

10

Contains DI Package

00858184006109

Package Discontinue Date

-

Package Status

In Commercial Distribution

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