DEVICE: Pathway (00852423006028)

A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

An assembly of devices intended exclusively for professional use in a healthcare facility 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; some types also perform electromyography (EMG) measurements. It consists of an electrically-powered external pulse generator/EMG/biofeedback unit with controls/display (e.g., hand-held remote control), software, and a cabled or cordless cylinder-like probe with surface electrodes for insertion into the vagina and/or anus. This is a reusable device.