L100 Go System

Stimulator, Neuromuscular, External Functional

Bioness Inc.

The following data is part of a premarket notification filed by Bioness Inc. with the FDA for L100 Go System.

Pre-market Notification Details

Device IDK200262
510k NumberK200262
Device Name:L100 Go System
ClassificationStimulator, Neuromuscular, External Functional
Applicant Bioness Inc. 25103 Rye Canyon Loop Valencia,  CA  91355
ContactMercedes Bayani
CorrespondentShanna Hu
Bioness Inc. 25103 Rye Canyon Loop Valencia,  CA  91355
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-03-04

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