InControl Medical Earns ISO and CE Mark

Women’s health company InControl Medical LLC has earned the ISO 13485 certification as well as the CE mark from the European Commission, both of which signify that the company meets comprehensive quality management requirements in the design and manufacture of medical devices.

InControl’s Intone device is listed by the U.S. Food & Drug Administration (FDA) as a Class II medical device for the treatment of female urinary incontinence. The Apex device is the first automatic pelvic floor exerciser for the over 20 million women in the United States suffering from unexpected bladder leakage due to coughing, sneezing, laughing or exercise often referred to “stress” incontinence. Finally Intensity is an intimate health and stimulation device designed to help women exercise the pelvic floor muscles for improved sexual health and responsiveness, while calming and relaxing those muscles to reduce pain.

“The global combination of ISO and CE mark quality conformance means that InControl Medical is well positioned to expand our growth internationally, in both established and emerging markets where consumers want and need the assurance of the highest medical device and performance standards,” said InControl CEO and founder Herschel “Buzz” Peddicord. “These designations, along with our FDA listing, are important tools that enhance the global reach and acceptance of our products for medical professionals and consumers.”