InControl Medical Gains FDA Clearance for InTone®MV Device
Providing women, who suffer with vaginal atrophy, a non-surgical, drug-free solution for stress, urge and mixed incontinence
BROOKFIELD, Wis.--(BUSINESS WIRE)--InControl Medical, LLC, a women’s health company focusing on female urinary incontinence, has received FDA clearance for their proprietary, patented, InTone®MV, providing women who suffer with vaginal atrophy a smaller, more comfortable medical device for the treatment of stress, urge and mixed female urinary incontinence without surgery or drugs. The InTone®MV technology was developed by the makers of InTone®, FDA listed as a Class II Medical Device for the treatment of female urinary incontinence.
“While InTone® has helped countless women solve the embarrassing and uncomfortable issue of involuntary loss of urine, InTone®MV allows us to help an even greater number of women who experience vaginal atrophy”
“While InTone® has helped countless women solve the embarrassing and uncomfortable issue of involuntary loss of urine, InTone®MV allows us to help an even greater number of women who experience vaginal atrophy,” said Herschel Peddicord, founder and CEO of InControl Medical. “Vaginal atrophy is a common complaint among menopausal women or those who have had a vaginal hysterectomy. Often atrophy is accompanied by incontinence and InControl recognized the need for a smaller device designed just for them.”
Both the InTone® and InTone®MV devices combine muscle stimulation with voice-guided pelvic floor exercise, visual biofeedback, and a unique, customizable probe to create a home-based treatment for incontinence. This comprehensive approach provides users with an easy-to-use program without pain, pills or side-effects.
InControl Medical, LLC is responsible for developing and marketing solutions for women’s urinary incontinence including InTone®, Apex® and Intensity® and has received ISO 13485 certification from the International Organization for Standardization (ISO) and the CE mark of the European Commission (EC), signifying that it meets comprehensive quality management requirements in the design and manufacture of medical devices. All products are available online at www.incontrolmedical.com.