NUTRAC PELVATOR, MODEL PEL 200

Stimulator, Electrical, Non-implantable, For Incontinence

VERITY SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Verity Scientific Ltd. with the FDA for Nutrac Pelvator, Model Pel 200.

Pre-market Notification Details

Device IDK083704
510k NumberK083704
Device Name:NUTRAC PELVATOR, MODEL PEL 200
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant VERITY SCIENTIFIC LTD. 4663 KATE LANE Oxford,  OH  45056
ContactBrent Reider
CorrespondentBrent Reider
VERITY SCIENTIFIC LTD. 4663 KATE LANE Oxford,  OH  45056
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-15
Decision Date2009-07-14
Summary:summary

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