Leva Pelvic Health System

Perineometer

Renovia Inc.

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

Pre-market Notification Details

Device IDK212495
510k NumberK212495
Device Name:Leva Pelvic Health System
ClassificationPerineometer
Applicant Renovia Inc. 263 Summer St. 5th Floor Boston,  MA  02210
ContactJim O'connor
CorrespondentJacqueline Schmainda
Bold Type 2100 N. Alafaya Trail Orlando,  FL  32826
Product CodeHIR  
CFR Regulation Number884.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-09-08

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