The Leva® Pelvic Health System is intended for: (i) strengthening of the pelvic floor muscles; (ii) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women; and (iii) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. This product interacts with the user via smartphone technology.


Important Safety Information for the Leva Pelvic Health System: Do not share the Leva system. Leva is a single-user medical device. Do not use the Leva Pelvic Health System while pregnant, or if you think you may be pregnant, unless authorized by your healthcare provider. Do not leave the Leva vaginal wand in your body for longer than necessary to complete the training session. Remove the vaginal wand after each training session. Do not use the Leva Pelvic Health System in any other place in your body. Do not have sexual intercourse while the vaginal wand is inserted. If you experience odor, fever, vomiting, diarrhea, any signs of infections or any flu-like symptoms, contact your doctor immediately. If you experience redness or swelling near the insertion area, or signs of an allergic reaction, contact your healthcare provider immediately For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com. Treatment with the Leva Pelvic Health System is prescribed by your healthcare provider. This treatment is not for everyone. Please talk to your healthcare provider to see if it is right for you. Your healthcare provider should discuss all potential benefits and risks with you.