WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000

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, Models 20-0100, 20-0310, 20-1000.

Pre-market Notification Details

Device IDK052329
510k NumberK052329
Device Name:WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
ClassificationStimulator, Neuromuscular, External Functional
Applicant INNOVATIVE NEUROTRONICS INC. TWO BETHESDA METRO CENTER SUTE 1200 Bethesda,  MD  20814
ContactFayyaz Memon
CorrespondentFayyaz Memon
INNOVATIVE NEUROTRONICS INC. TWO BETHESDA METRO CENTER SUTE 1200 Bethesda,  MD  20814
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-25
Decision Date2005-09-21
Summary:summary

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