NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR

Stimulator, Nerve, Transcutaneous, For Pain Relief

IBRAMED EQUIPAMENTOS MEDICOS

The following data is part of a premarket notification filed by Ibramed Equipamentos Medicos with the FDA for Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator.

Pre-market Notification Details

Device IDK121369
510k NumberK121369
Device Name:NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura,  FL  33180
ContactLilian Llull
CorrespondentLilian Llull
IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura,  FL  33180
Product CodeGZJ  
Subsequent Product CodeGZI
Subsequent Product CodeIPF
Subsequent Product CodeLIH
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-07
Decision Date2012-12-19
Summary:summary

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