Scrambler Therapy MC-5 A Device

Stimulator, Nerve, Transcutaneous, For Pain Relief

Delta International Services & Logistics S.r.l

The following data is part of a premarket notification filed by Delta International Services & Logistics S.r.l with the FDA for Scrambler Therapy Mc-5 A Device.

Pre-market Notification Details

Device IDK142666
510k NumberK142666
Device Name:Scrambler Therapy MC-5 A Device
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant Delta International Services & Logistics S.r.l Piazza Cavour 17 Rome,  IT 00193
ContactDonatella Ruscito
CorrespondentMariella Giorgieri
Delta International Services & Logistics S.r.l Piazza Adriana 4 Rome,  IT 00193
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-18
Decision Date2015-05-22
Summary:summary

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