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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name perineometer
510(k) Number K212495
Device Name Leva Pelvic Health System
Renovia Inc.
263 Summer St. 5th Floor
Boston,  MA  02210
Applicant Contact Jim O'Connor
Bold Type
2100 N. Alafaya Trail
Orlando,  FL  32826
Correspondent Contact Jacqueline Schmainda
Regulation Number884.1425
Classification Product Code
Date Received08/09/2021
Decision Date 09/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No