Rhinomed confirmed that it's revolutionary new ProntoTM rechargeable, dual action, vapour release technology has been registered with both the US FDA and the Australian TGA as a class I medical device. Regulatory clearance in two critical markets: In the USA, Rhinomed has now completed registration of Pronto covering both variants - Pronto Sleep and Pronto Clear - as a Class I medical device with the US FDA under Device Classification Name: Dilator, Nasal, Product Code: LWF Regulation Number: 874.3900 In Australia, Rhinomed can confirm the classification of Pronto as a Class I medical device for the ARTGA under Rhinomed's existing TGA listing under the same product category as its Mute and Turbine products and the same GMDN Code: 47607 Nasal Breathing aid, internal, reusable. Revolutionary new ProntoTM technology suite Based on the company's existing BreatheAssistTMnasal dilator technology (MuteTM and TurbineTM), the new ProntoTM OTC range includes the novel AirstreamTM release system that allows a continuous release of an essential oil blend into the nasal airstream over a set period of time. By combining this new vapour release technology with the Mute's stenting action, Rhinomed provides users with a unique dual action device that not only improves nasal airflow but also delivers a soothing blend of pure essential oils traditionally known to help clear a stuffy nose or to help sleep better naturally. Pronto also includes a novel recharging and storage case that allows Pronto to be recharged before each use. When Pronto is stored in its case in the recharge position, the Pronto device is replenished with the essential oil formulation so it is ready for use again.