RECIPROCAL LABS CORPORATION Sensor Model 2018-S Propeller

The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for theSymbicort device.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual userentry, to a remote storage system. With the Propeller Mobile Application the user can review information collected fromthe pMDI sensor, and report and review symptoms and other information about their disease management and its impact.The user may also share their information with their caregivers, physician, and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users toreview the collected information and characteristics of their pMDI and its use, to capture other patient-reportedinformation and outcomes, and to allow that information to be shared with their caregivers, physicians, and health careproviders.When used with a prescribed pMDI, the system can report on information captured during the normal course of use, suchas the time between actuations that can be helpful in assessing pMDI technique.The Propeller System is intended to be used in populations from Child (>2 years) to Adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use ofpMDI medication(s) by a participant.The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician.The Propeller System is not intended for use as an pMDI dose counter, nor is it intended to indicate the quantity ofmedication remaining in an pMDI.