c0f37d3b-c190-4603-9b30-65965cca472eUpdatePublished22026-01-052020-09-23In Commercial Distribution04719878320115PrimaryGS1iNAP22000-0722000-07657169335SOMNICS, INC.1iNAP Saliva ContainerfalsefalsefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseMR Unsafetruefalse1-833-766-6427service.us@somnics.com65078Intraoral negative-pressure sleep apnoea unitAn electrically-powered device intended for home management of obstructive sleep apnoea (OSA) by using low, negative air pressure in the mouth to pull the soft palate and tongue forward to increase the patency of the pharynx; this repositioning obstructs oral breathing while allowing nasal breathing. It consists of a control unit containing a pump and sensor(s), to detect and adjust air pressure within the oral cavity, connected to a specially designed mouthpiece; it may in addition include associated items (e.g., saliva container, absorbent pad). This is a reusable device.falseActiveOZRIntraoral Pressure Gradient DeviceStorage Environment Atmospheric PressureStorage Environment HumidityStorage Environment Temperaturefalsefalse