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The BreatheSuite MDI Device is an electronic device intended for single-patient use of patients 5 years of age and older. It assists patients in recording and monitoring the actuations and technique of prescribed metered dose inhaler (MDI) usage. The BreatheSuite System is composed of the disposable, battery powered, portable BreatheSuite MDI Device and a mobile application. The BreatheSuite MDI Device is an accessory designed to work with an MDI by attaching to the top of the canister of the inhaler. The BreatheSuite MDI Device does not interfere with regular MDI usage and can be reattached with ease. The BreatheSuite MDI Device does not actuate the inhaler but rather gathers information based on manual MDI usage. The BreatheSuite MDI Device measures the parameters of MDI use and records them for review by the patient. The BreatheSuite application records, stores, and transmits usage events from the BreatheSuite MDI Device to a remote storage system. Furthermore, BreatheSuite MDI reminds the patient of important steps of MDI use through visual feedback in the BreatheSuite application. The output of the BreatheSuite System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The BreatheSuite system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI. The BreatheSuite MDI Device is not intended to replace a physician's advice or inhaler labels; patients are expected to always follow their doctor's advice and inhaler labels. The BreatheSuite System can be used both indoors as well as in home and work settings. The BreatheSuite System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.

The BreatheSuite MDI Device is a Metered Dose Inhaler (MDI) accessory that monitors inhaler usage and inhaler technique metrics. The BreatheSuite MDI Device mounts on top of an MDI to measure when and how patients use their inhalers. The device uses internal sensors to record parameters of MDI use and technique including date and time of usage; MDI shaking duration; coordination between MDI actuation and the start of inhalation; and inhalation duration. By pairing with the BreatheSuite app via Bluetooth Low Energy (BLE) communications, the user receives reports on each inhaler dosage and on their inhalation technique. The user may share their use and technique information with their physicians and/or healthcare providers.