Geko™ W-2

Stimulator, Muscle, Powered

Firstkind Limited

The following data is part of a premarket notification filed by Firstkind Limited with the FDA for Geko™ W-2.

Pre-market Notification Details

Device IDK193045
510k NumberK193045
Device Name:Geko™ W-2
ClassificationStimulator, Muscle, Powered
Applicant Firstkind Limited Hawk House, Peregrine Business Park High Wycombe,  GB Hp13 7dl
ContactNeil Buckley
CorrespondentSheila Hemeon-heyer
Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst,  MA  01002
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
510k Review PanelPhysical Medicine
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-01
Decision Date2020-01-18

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