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The BreatheBand® device is intended to deliver high-frequency chest wall oscillation (HFCWO) therapy to promote airway clearance and aid in general bronchial drainage when external chest manipulation or manipulation of the thorax is the physician's treatment of choice to enhance mucus transport.

It is indicated for adult patients (22 years of age and older) experiencing difficulty with secretion clearance.

The BreatheBand® device is intended for use in the home-care environment.

The BreatheBand® device is non-invasive, reusable, and intended for single-patient use.

The BreatheBand® Model 1000 (BreatheBand®) consists of the following major components:

• 2 Bands, each Band has 4 actuator 'Pods,' a control box, and fasteners.
• 1 Remote, which is a touchscreen device for controlling the Bands.
• 3 Charging Power Supplies for charging both Bands and the Remote simultaneously.
• 1 Carrying Case, which can house and protect the system when not in use.
• 1 Instructions For Use (IFU) document.

The Bands are worn across the thorax in an "X" configuration as demonstrated in the IFU. The Remote communicates with the Bands to control the actuators' settings, such as frequency, intensity, and duration of treatment, to implement the prescribed treatment as specified by a physician. In addition, error messages are displayed on the Remote screen when indicated. The treatment status, such as settings and length of the treatment remaining, as well as the system status (battery levels), are displayed on the Remote screen.

The Bands are adjustable in terms of overall length (to fit larger or smaller torso sizes). Once adjustments are made to the fit, the user can remove and replace the Bands without re-adjusting.

Charging the Bands and Remote batteries is accomplished between therapy sessions, and the system will not provide therapy while connected to a charger. The battery capacity is sufficient for three typical therapy sessions on one full battery charge.

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