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510(k) Data Aggregation
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The LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended to resolve choking in a victim with a complete airway obstruction when a current choking protocol has been followed without success. LifeVac should only be used to remove an object/food from a victim with a complete airway obstruction. LifeVac is intended for use on adult or pediatric choking victims who are at least 1 year of age. LifeVac can be administered by a lay person or a medical professional (18 years or older) in various settings including at home or nursing homes, restaurants, schools, and other outside environments.
LifeVac is a portable, non-powered, single-use, non-sterile device that generates suction to remove a complete foreign body airway obstruction from a choking victim after a standard choking rescue protocol has failed. The device consists of a plunger with a one-way valve. A face mask is attached prior to use. The LifeVac device with the attached mask is placed over the victim's nose and mouth creating a mask seal. The device handle is pressed down to compress the unit, which pushes the air out through the vent system on the bottom of the device and not into the patient. The handle is then quickly pulled up and negative pressure is generated to suction out the obstruction. The duration of suction is minimal. The device has a patented ball valve system which is designed to prevent any air from exiting through the mask. The valve also is designed to prevent air from pushing stuck food or foreign objects downward. This creates a one-way suction to remove the lodged object. The device is non-invasive and does not need to be placed into the oral cavity. LifeVac device is available as a Home Kit or Travel Kit. The device is the same in both kit presentations and the only difference is the Home Kit comes with 1 adult mask, 1 pediatric mask, and 1 practice mask while the Travel Kit does not include a practice mask.
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