Catalog Number

-

Brand Name

WalkAide Electrodes - package of 4

Version/Model Number

20-0500

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

K874469,K874469

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

4dc25057-518c-42ef-8f31-8bb6f81c80a6

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 16, 2016

Package DI Number

858184006086

Quantity per Package

10

Contains DI Package

00858184006079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton