Stimulator, Nerve, Transcutaneous, Over-the-counter

LifeCare Ltd.

The following data is part of a premarket notification filed by Lifecare Ltd. with the FDA for Livia.

Pre-market Notification Details

Device IDK183110
510k NumberK183110
Device Name:LIVIA
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant LifeCare Ltd. Zipori St.2 Tiberias,  IL 1424602
ContactAmnon Nahum Sharon
CorrespondentIrving L. Wiesen
Cohen, Tauber, Spievack & Wagner 420 Lexington Avenue - Suite 2400 New York,  NY  10170
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-08
Decision Date2020-05-04

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