Stimulator, Nerve, Transcutaneous, Over-the-counter

TimeWaver Production GmbH

The following data is part of a premarket notification filed by Timewaver Production Gmbh with the FDA for Healy.

Pre-market Notification Details

Device IDK191075
501k NumberK191075
Device Name:Healy
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant TimeWaver Production GmbH Schloss Kranzlin Darritzer Strab 6 Kranzlin,  DE 16818
ContactMartin Wittmann
CorrespondentDouglas Herrington
Herrington Consulting LLC 2885 Sanford Ave, SW #43083 Grandville,  MI  49418
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-23
Decision Date2019-11-22

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