Cutaneous Electrode Stimulator For Urinary Incontinence

Bio-Medical Research Ltd.

The following data is part of a De Novo classification by Bio-medical Research Ltd. with the FDA for Innovo.

Pre-market Notification Details

DeNovo IDDEN170049
Device Name:Innovo
ClassificationCutaneous Electrode Stimulator For Urinary Incontinence
Applicant Bio-Medical Research Ltd. parkmore Business Park West Galway,  IE H91nht7
ContactAnne-marie Keenan
Product CodeQAJ  
CFR Regulation Number876.5330 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
Date Received2017-09-18
Decision Date2018-11-06
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
15391533470494 DEN170049 000
15391533470487 DEN170049 000
15391533470470 DEN170049 000
15391533470463 DEN170049 000
15391533470456 DEN170049 000
15391533470449 DEN170049 000
15391533470432 DEN170049 000
15391533470425 DEN170049 000
15391533470418 DEN170049 000

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