WalkAide Electrodes - package of 4

GUDID 00858184006079

Transcutaneous Electrical Stimulation Electrode

INNOVATIVE NEUROTRONICS, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use
Primary Device ID00858184006079
NIH Device Record Key4dc25057-518c-42ef-8f31-8bb6f81c80a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameWalkAide Electrodes - package of 4
Version Model Number20-0500
Company DUNS791468734
Company NameINNOVATIVE NEUROTRONICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us
Phone888-884-6462
Emailinfo@ininc.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100858184006079 [Primary]
GS1858184006086 [Package]
Package: carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-16

Devices Manufactured by INNOVATIVE NEUROTRONICS, INC.

10858184006458 - WalkAide2021-02-19 WalkAide Oval Velcro Electrode, 1.5" x 3.25", 10-pack
20858184006455 - WalkAide2018-12-27 WallkAide Oval Velcro Electrode, 1.5" x 3.25", case of 14 each 10-pack
00858184006451 - WalkAide2018-12-27 WalkAide Oval Velcro Electrode, 1.5" x 3.25"
00858184006000 - WalkAide Unit2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
00858184006017 - WalkAide Kit2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
00858184006031 - WalkAide Kit for Japan2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
00858184006048 - WalkAide Kit for Demo Use2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
00858184006055 - WalkLink Unit2018-07-06 Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.