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The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.

The Monarch® Airway Clearance System Model 1000 (hereinafter referred to as Monarch®) consists of a garment which contains actuators together with the Main Control Box and pendant controller. The Main control box contains the electronics used to control the actuators which are organized into 8 discrete zones. The pendant controller is tethered to the garment and consists of an LCD display and selection controls to facilitate visual feedback of the therapy and system information while allowing the user to adjust the therapy settings to adhere to the prescribed therapy ordered by the physician. It has adjustment mechanisms over each shoulder and on each side of the mid torso area to provide the wearer with a personal and evenly distributed snug fit. The buckles on each side of the device together with the front zipper help provide a repeatable fitting by allowing the wearer to wear and remove the garment without making changes to the adjustment mechanisms. The product also includes an external charger for the battery and can run on either power source as per desired by the user. The major components to the Monarch® Airway Clearance System are: . Garment - which contains the "pods" Garment shell covers the underlying the garment ● Pendant controls the device function ● Battery installed in the backpack cover ● Garment adjustment mechanisms means to secure and adjust the fit of the Garment to the user . This submission is specific to an expansion of the contraindication related to active implants. The device is identical to that cleared under K163378.