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Leva Pelvic Health System

Axena Health, Inc. · Model Leva-02 · UDI-DI 00860002994406

HIR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Leva Pelvic Health System (“Leva PHS” or “Leva System”) is a prescription intra-vaginal device designed to allow the user to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The Leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient’s mobile device. The Leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.

Recalls

Date	Firm	Reason
2019-07-12	Ralston Group	The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the de

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.