INNOVO

Cutaneous Electrode Stimulator For Urinary Incontinence

Atlantic Therapeutics Ltd.

The following data is part of a premarket notification filed by Atlantic Therapeutics Ltd. with the FDA for Innovo.

Pre-market Notification Details

Device IDK192357
510k NumberK192357
Device Name:INNOVO
ClassificationCutaneous Electrode Stimulator For Urinary Incontinence
Applicant Atlantic Therapeutics Ltd. Parkmore Business Park West Galway,  IE H91 Nht7
ContactAnne-marie Keenan
CorrespondentAnne-marie Keenan
Atlantic Therapeutics Ltd. Parkmore Business Park West Galway,  IE H91 Nht7
Product CodeQAJ  
CFR Regulation Number876.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-29
Decision Date2020-01-16

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