StimRouter Neuromodulation System

Stimulator, Peripheral Nerve, Implanted (pain Relief)

Bioness Inc.

The following data is part of a premarket notification filed by Bioness Inc. with the FDA for Stimrouter Neuromodulation System.

Pre-market Notification Details

Device IDK211965
510k NumberK211965
Device Name:StimRouter Neuromodulation System
ClassificationStimulator, Peripheral Nerve, Implanted (pain Relief)
Applicant Bioness Inc. 25103 Rye Canyon Loop Valencia,  CA  91355
ContactSageev George
CorrespondentSageev George
Bioness Inc. 25103 Rye Canyon Loop Valencia,  CA  91355
Product CodeGZF  
CFR Regulation Number882.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-24
Decision Date2022-02-23

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