G.Estim FES

Stimulator, Muscle, Powered

G.tec Medical Engineering GmbH

The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for G.estim Fes.

Pre-market Notification Details

Device IDK200088
510k NumberK200088
Device Name:G.Estim FES
ClassificationStimulator, Muscle, Powered
Applicant g.tec Medical Engineering GmbH Siemingerstrasse 14 Schiedlberg,  AT 4521
ContactChristoph Guger
CorrespondentChristoph Guger
g.tec Medical Engineering GmbH Siemingerstrasse 14 Schiedlberg,  AT 4521
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-15
Decision Date2020-10-29

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