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The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies. electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).

The EVOX Electro-Diagnostic Device utilizes Laborie Urodynamic equipment 510(k) exempt under section § 876.1620 or with another microprocessor that is compatible with the required capability. The Laborie EVOX Electro Diagnostic Device will help diagnose and perform evaluation tests for urinary and fecal incontinence as well as other neurological and physiological assessment, including: Pudendal Nerve Terminal Motor Latency with St Marks Electrodes Anal Sphincter CN EMG Cerebral Pudendal Somatosensory Evoked Potential Sacral Reflexes Calculations will include: latency, peak, duration, conduction velocity and area. The equipment includes the Evox Electro-diagnostic Software and the hardware required to perform the stated tests which include: - Laborie 94-based Hardware with Integrated Electrodiagnostic Stimulation . - . Ring/Bar Stimulation Electrodes - Needle/Cup/Patch EMG/ECG Electrodes . - St. Mark's Electrode and Cable . - EMG/ECG Cabling .