Leva Pelvic Health System

Primary DI

00860002994406

Brand

Leva Pelvic Health System

Company

Axena Health, Inc.

Model

Leva-02

Device 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.

Published

2020-04-27

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true