510(k) K212495

Leva Pelvic Health System by Renovia, Inc. — Product Code HIR

K212495 is an FDA 510(k) premarket notification submitted by Renovia, Inc. for the device "Leva Pelvic Health System". The FDA issued a decision of Substantially Equivalent on September 8, 2021. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Renovia, Inc. has at least 3 other 510(k) clearances on record.