LEva Pelvic Digital Health System

Perineometer

Renovia Inc.

The following data is part of a premarket notification filed by Renovia Inc. with the FDA for Leva Pelvic Digital Health System.

Pre-market Notification Details

Device IDK192270
501k NumberK192270
Device Name:LEva Pelvic Digital Health System
ClassificationPerineometer
Applicant Renovia Inc. 263 Summer St., 5th Floor Boston,  MA  02210
ContactGina Prochilo-cawston
CorrespondentGina Prochilo-cawston
Renovia Inc. 263 Summer St., 5th Floor Boston,  MA  02210
Product CodeHIR  
CFR Regulation Number884.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
501k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2019-11-22

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