The Perifit device has recently received 510(k) clearance from the United States Food and Drug Administration (FDA). Developed by a Paris-based company, Perifit has been designed to help women improve their pelvic floor muscle strength, while also providing an interactive experience with mobile games.
The Perifit device is a small, connected device that is inserted into the vagina, and acts as a biofeedback tool to guide and monitor kegel exercises. The device connects to a mobile app, where users can play games that use the pelvic floor muscles to control gameplay. This approach makes kegel exercises more engaging, helping to encourage consistent use, which is essential for improving muscle strength.
The device was originally registered as a Class I medical device, which is the lowest risk classification for medical devices. The recent 510(k) clearance from the FDA means that the device can now be marketed and sold in the United States, following the completion of the premarket notification process. This process involves demonstrating that the device is substantially equivalent to an existing FDA-approved device, and that it is safe and effective for its intended use.
Pelvic floor muscle weakness can cause a range of health issues, including incontinence, prolapse, and sexual dysfunction. Kegel exercises, which involve contracting and relaxing the pelvic floor muscles, are often recommended by healthcare professionals as a way to improve muscle strength and reduce these symptoms. However, many women find kegel exercises to be boring or difficult to perform consistently, which can limit their effectiveness. The Perifit device provides a solution to this problem, making kegel exercises more engaging and potentially more effective.
The clearance of the Perifit device by the FDA represents an important milestone for the company. The device has the potential to improve the lives of many women who are struggling with pelvic floor muscle weakness.