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# Pelvital Flyte Urinary Incontinence Therapy Cleared
- URL: https://www.fdaweb.com/pelvital-flyte-urinary-incontinence-therapy-cleared/
- Published: 2020-08-21T12:00:00.000Z
- Updated: 2026-09-14T16:25:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147489

FDA has cleared a Pelvital 510(k) for Flyte, an intravaginal home-use device that is intended to strengthen the pelvic floor muscles to help women with stress urinary incontinence (SUI). “Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbo charges Kegel exercises, the gold standard conservative treatment for SUI,” the company says. Flyte’s five-minute-per-day treatment is intended to amplify the treatment impact of Kegels so women see results much sooner, it adds.