848e74af-7f23-4ad6-ba37-596ab1ce0f03UpdatePublished32019-01-082016-08-31In Commercial Distribution05060049630212PrimaryGS1MalemMO3S2291490076MALEM MEDICAL LIMITED1Malem Audio (MO3) enuresis alarm (sound 2, green)falsetruefalsefalsefalsefalsefalsefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse11588Incontinence sensor/alarmA electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.falseActiveKPNAlarm, Conditioned Response Enuresisfalsefalse