The Leva® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) 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 (3) 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 device interacts with the user via smartphone technology.
Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. Federal law restricts this device to sale by or on the order of a physician.
Recommended use
Two and one-half minutes, twice daily. Remove the vaginal wand after each use.
Contraindications
The Leva Pelvic Health System is contraindicated for uses other than those described by the indications for use.
Warnings
Please read this section carefully prior to using your Leva Pelvic Health System.
- Do not use your Leva Pelvic Health System while pregnant, or if you think you may be pregnant, unless authorized by your healthcare provider.
- Do not share your Leva Pelvic Health System with other users. The Leva Pelvic Health System is intended for use as a single-user medical device.
- Do not leave the Leva wand in your vagina for longer than necessary to complete the training session. Always remove the Leva wand after each training session and do not exceed 60 minutes of insertion, including during menstruation.
- Do not use the Leva wand in any other place in your body. The Leva wand is only intended to be used in the vagina.
- Do not have sexual intercourse while the Leva vaginal wand is inserted.
- Do not insert the Leva wand if there is any damage to any of the Leva Pelvic Health System components.
- Keep the Leva Pelvic Health System out of reach of children. If left unattended, the Leva Pelvic Health System could prove to be a choking hazard to a child and could result in death.
- If you experience redness or swelling near the insertion area, contact your doctor, as you may have an allergic reaction to the device material.
- Do not use your Leva wand and storage case adjacent to or stacked with other equipment as this may adversely impact normal operation of the device.
- The modification or use of the Leva Pelvic Health System with accessories other than those specified and sold by Axena Health, Inc. as replacement parts may result in increased emissions or decreased immunity of the Leva Pelvic Health System.
Precautions
Please familiar yourself with the following information for the safe and effective use of the device:
- Do not bend the Leva wand. Do not twist the Leva wand.
- Do not submerge the Leva wand or case in water or liquid.
- Do not use the Leva Pelvic Health System in the shower or bathtub, and do not submerge it in liquid of any kind. The Leva Pelvic Health System is not designed to be used underwater.
- Do not submerge the battery in any kind of liquid or expose to running water when detached from vaginal wand.
- Do not bathe, shower, swim, or submerge yourself in water while Leva wand is inserted.
- Do not use the toilet while Leva wand is inserted.
- Do not soak the Leva Pelvic Health System.
- Do not put the Leva Pelvic Health System in the dishwasher.
- Do not clean Leva with anything but mild soap and water.
- Do not use oil or petroleum-based lubricants with the Leva wand. Use water-based lubricants only.
- Do not leave Leva in the sun, near an open fire, or in a hot parked car. Excessive or direct heat can damage the Leva Pelvic Health System.
- Do not modify the Leva Pelvic Health System in any way or use it in combination with any accessory not mentioned in this document. This could result in deformation of the Leva which could cause painful insertion or could damage the electronics.
- Always wash your hands before inserting the Leva wand to prevent harmful bacteria, which may be present on your hands, from entering your vagina.
- Always ensure there are no obstructions present when inserting the Leva wand.
- Always ensure you can maintain your balance when inserting the Leva wand and operating the Leva Pelvic Health System.
- To ensure hygienic safety, you should clean and dry your Leva wand before and after each treatment session
For complete risk information and instructions, review the current Leva Pelvic Health System Instructions for Use.
Customer Support & Product Complaints
For questions, support, or to report a product complaint related to Leva, please contact Axena Health at 1-855-367-5382.
PM-000460.01