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The Reza Band® UES Assist Device is indicated for patients 18 years and older to reduce the symptoms of larvngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The device is worn by the patient when sleeping.

The Reza Band® UES Assist Device (Reza Band) (Figure 1) is a non-invasive, non-sterile device worn by the patient and is designed to provide a set pressure (20-30 mm Hg) on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES). The patient wears the Reza Band after being fit by the physician (Figure 2). The Reza Band has 5 main components: - Frame - Cushion - Comfort Band - Clasp - Comfort Dial The Reza Band® External Manometer (External Manometer) is a hand-held device and is connected to the Reza Band® Pressure Sensor (Pressure Sensor). It is used by the treating physician, is powered by a AAA battery and displays the pressure being applied to the cricoid cartilage region by the Reza Band in millimeters of Mercury (mm Hg) as the Reza Band® is being fitted (Figure 3). The Pressure Sensor connected to the External Manometer is regulated as a miniature pressure transducer (21 CFR Part 890.1615) which is Class I exempt. The Pressure Sensor and the External Manometer were assessed to ensure that the Reza Band® was accurately applying the specified pressure.