The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles.It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control.Stimulator, Electrical, Non-implantable, for Incontinence –Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPIRegulation Number: 21 CFR 876.5320Regulatory Class: II
A device or device assembly available for use by a patient/layperson outside a clinical setting designed to treat urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., hand-held remote control) intended for wired or wireless connection to a cylinder-like probe with surface electrodes designed to be inserted into the vagina and/or anus; the probe may be included in the device assembly. This is a reusable device.