The leva Pelvic Digital Health System (leva PDHS) is intended for: (i) strengthening of the pelvic floor muscles; and (ii) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women. This product interacts with the user via smartphone technology.

No. leva is only available via a Medical Order through your doctor.

Payment plans are available for the levaes through one of our distribution partners. If you cannot afford your kit, please contact us at (866) 735-8423.

Co-pay assistance is not available at this time.

Once your Medical Order is received one of our distributor partners will contact you to process your insurance and coordinate delivery. Upon receipt of your order, Renovia’s Women’s Center will contact you to set up your leva, provide urinary incontinence/urinary leakage education, ongoing support, and to help schedule a product training session. Additionally, if you have any questions, please call Renovia at (866) 735-8423.

After your leva^es prescription has been filled and shipped, you will be contacted by Renovia to help you register your product and download the your leva app, provide urinary incontinence/urinary leakage education and to discuss your options to learn how to use the leva and help schedule leva product training. Training options include in-office training, and at-home individual training using Renovia’s Women’s Center and their resources. If at any time you have questions or need assistance, Renovia’s Women’s Center is available to help. We can be reached at (866) 735-8423.

It is important that you are provided the proper training in how to use your leva. It is recommended that you receive training by a pelvic floor trainer at your physician’s office or at a pelvic floor physical therapist’s office. This is an important step in starting to use the leva, as recommended by your doctor.

You should not experience pain when inserting leva into your vagina or when using the leva. Please review the IFU carefully before you use leva. If you experience pain during insertion or during or after use, please contact your health care provider.

If you find it difficult to insert, you may use water alone or, if needed, a small amount of waterbased lubricant (NOT petroleum jelly or petroleum based products). Use a very small amount of lubricant on and around the very tip of leva and this should help with insertion. If leva has been inserted correctly, you should not feel any discomfort.

No. If you wash your hands and clean leva properly, as instructed, the product will not cause an infection. The materials used in manufacturing leva have been thoroughly tested and are safe. A small number of people may be sensitive to the materials used in making leva, but most women can use leva without any trouble.

No. All the electronics are completely covered with medical grade silicone, with no exposed parts. Silicone is frequently used in many medical devices for many different purposes and leva has been thoroughly tested for safety.

No. leva goes into the vagina. The opening near the top of the vagina is called the cervix. The cervix is very small, and leva is too large to go through it. The leva will stay in the vagina until you decide to remove it.

No. If you have a hard time removing it, it could be because you are tense and are squeezing your vaginal muscles. Take a deep breath and try to relax. Once you have relaxed, leva should come out easily.

No. The electronics are completely covered in medical grade silicone and leva has gone through rigorous safety testing. If you see an opening or if leva has been punctured or damaged in any way, please discontinue use immediately.

No. leva is not waterproof. Please read the Instructions for Use manual carefully before you start using leva. Although you must wash the leva probe, you cannot use leva in the shower, bathtub or submerge it in liquid of any kind. leva is not designed to be used underwater.

Always remember to wash your hands and your leva after every use. After washing your leva either allow it to air dry or dry it with a clean towel and store your leva in a clean dry container. It is recommended to store your leva in the supplied box or in a hard case to avoid bending the probe, which may result in damaging the sensors. Do not bend or wrap the wire around the device, as this also may result in damaging the sensors.

No. It is a single-user product. It is for your personal use. Do not share leva with anyone.

No. Do not use the leva while pregnant, or if you think you may be pregnant, unless recommended by your doctor.

Yes. You can use leva when you are menstruating. Do not use leva when wearing a tampon. If using leva during your period makes you uncomfortable, waiting a week will not change anything.

No. It is recommended to use leva while standing because it will give you the best reading while performing your pelvic floor muscle training.

Yes, if you would like to, you may choose to do so.

No. leva is prescribed to help you strengthen your pelvic floor muscles.

leva is made of medical grade silicone.

Latex and silicone are two different products. Latex is a natural product and silicone is a man-made product. leva is made of medical grade silicone. Please talk to your healthcare provider if you have any concerns.

In Training Mode, the red zone is the resting zone.

There is no ideal score as each person is different. However, the goal is to continue to increase your score as you perform your pelvic floor muscle training over time.

Up. The goal is to continue to increase your score as you perform your training.

There may be some days where your scores go down compared to some of your historical scores. If you find that your scores decrease over time contact your healthcare provider for guidance.

Flickering occurs on the app when your pelvic floor muscles get stronger and as a result, your leva may rotate or turn while inserted in the vagina. To correct, remove your leva and re-insert to start your pelvic floor muscle training over.

Try turning leva and your smartphone device off, then turning them on again. If that is unsuccessful, please contact the Renovia Women’s Center at (866) 735-8423 as they will be able to help you further.

Check the position of your leva to make sure the line and logo on the probe are facing out. Are you sure you are lifting and not bearing down? An easy way to check is to try leva in Practice Mode. In this mode, you can see the leva moving even if you are bearing down.

leva is soft and pliable, and conforms to the shape of your vagina.

To save battery life the Bluetooth® light only stays on for a few seconds when you first turn the device on.

This could be related to how relaxed you were when you started your training session. To get out of the red zone, you must be relaxed before you start your training. Practice lifting in Practice Mode until your lifts are outside the resting zone range, then return to using the Training Mode.

The blinking line on the app means you need to reposition the probe to ensure the line is facing out.

Try turning leva and device off, then turning them on again. If that is unsuccessful, please contact Renovia Women’s Center at (866) 735-8423 as they will be able to help you further.

The your leva app is available for Android™ & iOS. Download the your leva app on Google Play and in the App Store.

Yes. The information that is in the Renovia database that is accessible on the website is confidential. Please do not share your username or password with anyone that you do not want to share your information with.

You can login to the app during your visit and show your doctor your session history.

• You can login to https://leva.renoviainc.com/Account and PDF/print out your session history.
• • You can take screenshots of your session history while the app is open.

The your leva app stores up to 300 sessions, so once you have your session history you can either bring it with you to your visit or you can forward it to your doctor electronically.

Renovia Inc acquired the worldwide intellectual property (IP) license of the leva® Pelvic Digital Health System from Remendium Labs. Renovia Inc was formed to discover and deliver innovative medical solutions and technology combined with digital health to help individuals suffering from pelvic floor disorders. The leva system underscores our commitment to bring innovative products to women suffering from specific pelvic floor conditions.

Remendium Labs is the former owner of the leva system.

Our distribution partners are Foundation Care Pharmacy, Better Living Now, Inc. (BLN) and Edwards Health Care Services, Inc. (EHCS). For more information, please visit our Distributors page.