WalkAnalyst Software Kit

GUDID 00858184006130

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 the user.

INNOVATIVE NEUROTRONICS, INC.

Gait-enhancement electrical stimulation system, external
Primary Device ID00858184006130
NIH Device Record Key3f184751-8a04-4b5a-84ae-d6c6186c9530
Commercial Distribution StatusIn Commercial Distribution
Brand NameWalkAnalyst Software Kit
Version Model Number20-0603
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 Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858184006130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZIStimulator, Neuromuscular, External Functional

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
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