ZIDA Wearable Neuromodulation System

Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction

Exodus Innovations

The following data is part of a premarket notification filed by Exodus Innovations with the FDA for Zida Wearable Neuromodulation System.

Pre-market Notification Details

Device IDK192731
510k NumberK192731
Device Name:ZIDA Wearable Neuromodulation System
ClassificationStimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction
Applicant Exodus Innovations 1 Exodus Road Sufa,  IL 85457
ContactIsaac Oppenheim
CorrespondentCherita James
M Squared Associates, Inc 575 8th Ave Suite 1212 New York,  NY  10018
Product CodeNAM  
CFR Regulation Number876.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2021-03-19

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