We recommend using our Gel to get the most. Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Developer of FDA Cleared medical devices designed to treat female incontinence and sexual dysfunction. Incontrol Medical Gel is a hypoallergenic and salt-free electrode gel, for use with Incontrol Medical devices. InControl plans to expand its products to other markets throughout this year, Peddicord said. and all of InControl devices are handmade. It sources all of its materials in the U.S. PMA PMN De Novo MAUDE GUDID NDC DailyMed Drug Applications INCONTROL Stimulator, Electrical, Non-implantable, For Incontinence INCONTROL MEDICAL, LLC. The company manufactures its products at its Brookfield, Wisconsin facility. FDA premarket device registration for Incontrol distributed by INCONTROL MEDICAL, LLC. In contrast to InTone and InToneMV, which treat stress, urge and mixed incontinence, Apex uses a muscle stimulation algorithm and a probe to strengthen pelvic floor muscles to prevent leakage following childbirth or menopause. InControl Medical’s products have so far helped over 170,000 people gain control of their urinary and bowel functions by solving the issues that cause incontinence. News of the expanded indication came as InControl is launching its InTone and Apex product lines in New Zealand. “InToneMV allows us to expand our product line to help both men and women suffering with urinary and fecal incontinence,” InControl CEO and founder Herschel Peddicord said. InControl Medical (ICM) designs and manufactures devices to treat urinary and fecal incontinence. InTone, from InControl Medical, is a combination therapy device designed to treat. The company likens the system to in-home physical therapy, with the voice technology serving as a coach. Innovo develops and manufactures medical devices to help people restore their pelvic floor and treat bladder weakness. This is the most common bladder control problem in younger women. The system comprises an inflatable insertion unit and a voice-guided series of pelvic floor exercises dictated through a handheld control unit. Originally cleared in mid-February to treat urinary incontinence in women, the device got a green light at month’s end for use in treating urinary and fecal incontinence in men and women. InControl Medical said Tuesday it has received FDA clearance on an expanded indication for its InToneMV incontinence device.
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