Cionic Neural Sleeve NS-100

Stimulator, Neuromuscular, External Functional

CIONIC

The following data is part of a premarket notification filed by Cionic with the FDA for Cionic Neural Sleeve Ns-100.

Pre-market Notification Details

Device IDK221823
510k NumberK221823
Device Name:Cionic Neural Sleeve NS-100
ClassificationStimulator, Neuromuscular, External Functional
Applicant CIONIC 1606 Stockton St, Suite #1 San Francisco,  CA  94133
ContactMihai Ionescu
CorrespondentMihai Ionescu
CIONIC 1606 Stockton St, Suite #1 San Francisco,  CA  94133
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-23
Decision Date2022-07-21

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