InControl Medical, a women’s health company focusing on female urinary incontinence, has received the US Food and Drug Administration (FDA) clearance for its proprietary, patented, InToneMV.
The device provides women who suffer with vaginal atrophy a smaller, more comfortable option for the treatment of stress, urge and mixed female urinary incontinence without surgery or drugs.
According to the company, lnToneMV is substantially equivalent to the predicate device, InTone (K110179) and is a modification of the predicate device.
InControl Medical founder and CEO Herschel Peddicord said while InTone has helped countless women solve the embarrassing and uncomfortable issue of involuntary loss of urine, InTone MV allows company to help an even greater number of women who experience vaginal atrophy.
"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," Peddicord added.
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.