Elitone: An FDA-Cleared Incontinence Device

Elitone is an FDA-cleared medical device specifically designed to treat urinary incontinence—not simply a pelvic wellness product or exercise aid. Because FDA clearance applies to a device’s specific intended use, it is important to understand what a product is actually cleared to do. This article explains what FDA clearance means, how Elitone differs from general pelvic floor trainers, and how its clearance is supported by clinical research.

Updated: August 15, 2026
Author: Elitone Medical Staff

Woman speaking with her doctor about FDA-cleared treatment options for urinary incontinence

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Many products promise to strengthen the pelvic floor, improve bladder control or help women feel more confident. But a pelvic wellness product, exercise app or general muscle stimulator is not necessarily a medical treatment for urinary incontinence.

Elitone is different. Elitone is an FDA-cleared, non-implanted muscle stimulator specifically designed to treat stress urinary incontinence in women. Other products in the Elitone family have received separate FDA clearances for urge urinary incontinence in women and early continence recovery in men following prostate surgery.

Understanding that distinction can help you evaluate products based on what they have actually been reviewed and cleared to do.

What Does FDA-Cleared Mean?

Most Class II medical devices reach the United States market through the FDA’s 510(k) process. Through this process, a manufacturer provides detailed information about a device’s intended use, technology, design, performance and safety.

The FDA then determines whether the device is substantially equivalent to an appropriate legally marketed device. Substantially equivalent does not mean that two devices must be identical. It means that the new device has the same intended use and is considered as safe and effective as the legally marketed device to which it is compared.

Depending on the device, supporting information may include:

  • Electrical safety and electromagnetic compatibility testing
  • Software verification and validation
  • Biocompatibility evaluation
  • Engineering and performance testing
  • Usability testing
  • Published clinical literature
  • Clinical testing with the device

Elitone’s FDA submission included electrical safety, software, electrode-performance, biocompatibility and usability evaluations. It also included a clinical literature review and results from a clinical study of women with stress urinary incontinence.

FDA-Cleared vs. FDA-Approved

“FDA-cleared” and “FDA-approved” are not interchangeable terms.

FDA approval generally refers to the premarket approval process used for higher-risk Class III medical devices. FDA clearance generally refers to a 510(k) determination that a device is substantially equivalent to an appropriate legally marketed device.

Elitone is correctly described as FDA-cleared. It should not be described as FDA-approved.

Why the Cleared Indication Matters

FDA clearance applies to a device’s particular intended use. It is not a general endorsement that allows a product to make any medical claim.

For example, an electrical stimulation device may be cleared for temporary pain relief or general muscle conditioning without being cleared to treat urinary incontinence. A biofeedback device may help users identify pelvic floor contractions but may not independently provide treatment. Other products may be marketed as wellness or exercise products rather than medical devices.

Therefore, the most useful question is not simply:

“Is this product FDA-cleared?”

It is:

“What exactly is this product FDA-cleared to do?”

Elitone’s FDA indication specifically states that it is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. This is the type of leakage that commonly occurs during coughing, sneezing, laughing, lifting or exercise.

Medical Treatment vs. Pelvic Wellness

Products described as pelvic floor trainers can serve very different purposes. Before purchasing one, look beyond terms such as “FDA-cleared,” “EMS,” “Kegel trainer” or “pelvic wellness.” Verify the product’s specific intended use and whether it actively treats urinary incontinence.

Type of productWhat it may doWhat to verify
Pelvic floor exercise appProvides instructions, reminders or guided exercisesIs it a medical device or a general wellness product?
Biofeedback or perineometer deviceMeasures muscle activity or shows whether the user is contracting the intended musclesIs it cleared only for measurement or also for treatment?
General EMS or TENS deviceStimulates muscles or nerves for purposes such as conditioning or pain reliefIs its FDA-cleared indication specifically for urinary incontinence?
Internal pelvic floor stimulatorDelivers stimulation through an inserted vaginal or rectal probeWhich symptoms does it treat, and is a prescription required?
External incontinence-treatment deviceDelivers treatment through electrodes placed on the skinWhich type of urinary incontinence is included in its cleared indication?
ElitoneDelivers external neuromuscular stimulation to the pelvic floor muscles and surrounding tissuesChoose the Elitone treatment that matches the type and cause of the leakage

A general category cannot tell you everything about an individual product. Always check the manufacturer’s labeling, instructions and specific FDA record.

Elitone FDA Clearances

Elitone products are classified as transcutaneous electrical continence devices. “Transcutaneous” means the stimulation is delivered through the skin rather than through an inserted probe.

Elitone for Women With Stress Incontinence

Elitone received FDA clearance in 2019 under 510(k) K183585. Its indication identifies Elitone as a non-implanted muscle stimulator designed to treat stress urinary incontinence in women by applying stimulation to the pelvic floor muscles and surrounding tissues.

Elitone is available over the counter and does not require a prescription for direct purchase. It is worn externally in the perineal area, where a normal bladder-leak pad would ordinarily be placed.

Elitone URGE for Urge Incontinence

Elitone Urge received a separate FDA clearance under 510(k) K223884. It is designed to treat urge urinary incontinence in women, which involves sudden urges to urinate and leakage before reaching a bathroom.

Elitone Urge uses a different stimulation program from Elitone because urge incontinence and stress incontinence involve different bladder-control problems.

Elitone for Men Following Prostate Surgery

Elitone for Men received FDA clearance under 510(k) K253285. It is designed to aid early continence recovery in men immediately following prostate surgery.

Although the products share an external, wearable design, each is intended for a particular patient population and bladder-control problem. Users should select the product that matches their symptoms and follow its instructions for use.

FDA Clearance and Clinical Evidence

FDA clearance and clinical evidence are related, but they are not the same thing.

FDA clearance establishes that a device may be marketed for its specified intended use following the FDA’s review. Clinical studies separately evaluate what happens when people use the device, including changes in leakage, pad use and quality of life.

In a clinical study of women with stress urinary incontinence who used Elitone for six weeks:

  • 95% reported fewer leaks.
  • Average leakage was reduced by 71%.
  • Participants also reported reduced pad use and improved quality of life.

Elitone Urge has been studied separately in women with urge and mixed urinary incontinence. In that patient series, 97% of participants improved and 85% achieved a reduction of more than 50% in urge-related accidents after six weeks.

These results provide important evidence about patient outcomes, but this page is not intended to reproduce every study or methodology. Visit The Science Behind Elitone for clinical results, study descriptions and additional information about the technology. Individual results can vary.

How Elitone Treats Incontinence

Your brain normally communicates with muscles and nerves through electrical signals. Neuromuscular electrical stimulation uses controlled signals to activate or influence the tissues involved in bladder control.

Elitone delivers these signals externally through a flexible GelPad placed against the perineal area. The controller offers 35 adjustable intensity levels, allowing the user to gradually increase treatment to a strong but comfortable level.

For stress urinary incontinence, Elitone produces repeated pelvic floor contraction and rest cycles. A 20-minute session delivers 100 contractions and rest cycles, doing Kegels for you longer and stronger. Treatment can be completed while the user remains dressed and moves around normally.

Elitone Urge uses a different, lower-frequency stimulation pattern intended to calm the bladder-control pathways associated with urgency. It does not produce the same repeated pelvic floor contractions as the stress-incontinence treatment.

For a more technical explanation of neuromuscular stimulation, frequency, waveform design and the difference between EMS and TENS, read Electrical Stimulation for Incontinence.

Choosing the Right Elitone Treatment

The right treatment depends on the type and cause of the leakage:

  • Stress incontinence: Leakage during coughing, sneezing, laughing, lifting or exercise may indicate weakened pelvic floor support. Explore Elitone.
  • Urge incontinence: Sudden, difficult-to-control urges followed by leakage may indicate overactive bladder. Explore Elitone Urge.
  • Mixed incontinence: Women who experience both stress-related and urgency-related leakage should consider which symptoms are most troublesome and may benefit from discussing treatment selection with a healthcare professional.
  • Leakage following prostate surgery: Men in the early recovery period after prostate surgery can learn about Elitone for Men.

If you are uncertain about your symptoms, review the different types of urinary incontinence or speak with a healthcare professional before choosing a treatment.

Elitone products provide an important combination: a specific FDA-cleared medical indication, external at-home treatment and supporting clinical research. That is a meaningful difference from a device that only measures pelvic floor activity, guides exercises or provides general-purpose electrical stimulation.

Frequently Asked Questions

Is Elitone FDA-approved?

Elitone is FDA-cleared, not FDA-approved. It received clearance through the FDA’s 510(k) process as a Class II transcutaneous electrical continence device.

Is Elitone FDA-cleared specifically for urinary incontinence?

Yes. The FDA indication for Elitone identifies it as a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. Elitone Urge has a separate clearance for urge urinary incontinence in women, and Elitone for Men is cleared to aid early continence recovery immediately following prostate surgery.

Does FDA clearance mean that Elitone is guaranteed to work for everyone?

No medical treatment works for every person. FDA clearance allows Elitone to be marketed for its specified indication following FDA review. Clinical studies provide additional evidence about outcomes among study participants, but individual results can vary.

Are all FDA-cleared pelvic floor devices cleared to treat incontinence?

No. FDA clearance is specific to a product’s intended use. A device may be cleared for measuring muscle activity, providing biofeedback, relieving pain or conditioning muscles without being cleared to treat urinary incontinence. Check the device’s actual FDA indication rather than relying on the phrase “FDA-cleared” alone.

Does an EMS or TENS device automatically treat bladder leaks?

No. EMS and TENS describe forms of electrical stimulation, not the medical condition a device is cleared to treat. A general-purpose electrical stimulation device should not be assumed to treat urinary incontinence unless that use is included in its labeling and FDA clearance.

Is Elitone inserted into the vagina?

No. Elitone is completely external. Its GelPad is placed in the perineal area where a normal bladder-leak pad would ordinarily go. No vaginal probe or inserted component is used.

Do I need a prescription to purchase Elitone?

No. Elitone products are available over the counter for direct purchase. A prescription may still be required when seeking Medicare or other insurance coverage.

Where can I see Elitone’s clinical data?

Clinical findings, study descriptions and technical information are available on Elitone’s Science page. The FDA clearance records are also linked in the References section below.

References

  1. U.S. Food and Drug Administration. Premarket Notification 510(k).
  2. U.S. Food and Drug Administration. Elitone Device 510(k) Summary, K183585. February 11, 2019.
  3. U.S. Food and Drug Administration. Elitone URGE 510(k) Summary, K223884. February 24, 2023.
  4. U.S. Food and Drug Administration. Elitone for Men 510(k) Clearance, K253285. January 23, 2026.
  5. Elidah, Inc. The Science Behind Elitone.
Elitone is your easy to use at home solution for incontinence.

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