WALKAIDE SYSTEM

Stimulator, Neuromuscular, External Functional

INNOVATIVE NEUROTRONICS INC.

The following data is part of a premarket notification filed by Innovative Neurotronics Inc. with the FDA for Walkaide System.

Pre-market Notification Details

Device IDK123972
510k NumberK123972
Device Name:WALKAIDE SYSTEM
ClassificationStimulator, Neuromuscular, External Functional
Applicant INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY SUITE 150 Austin,  TX  78746 -3211
ContactGlen Neally
CorrespondentGlen Neally
INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY SUITE 150 Austin,  TX  78746 -3211
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-26
Decision Date2013-04-01
Summary:summary

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