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The CirQlator™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.

The CirQlator"M is an intrathoracic pressure regulator intended to interface with the airway of a patient and a ventilation source. A vacuum source is connected to the ITPR that provides continuous low-level vacuum except when a positive pressure breath is given by a ventilation source, e.g. manual resuscitator. The applied vacuum decreases the intrathoracic pressure. When interposed between positive pressure ventilations, a decrease in intrathoracic pressure has been shown to increase vital organ perfusion and decrease intracranial pressure during states of shock, cardiac arrest, and other low blood flow states in animal studies.

The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.

The Lifestyle Circulatory Enhancer (CE) device is a non-sterile, single user device that is used within the external airway channel. Inspiration through the Lifestyle CE device provides temporary circulatory enhancement. Temporary circulation enhancement increases blood pressure, which has a positive effect on the symptoms of orthostatic hypotension. The technology providing temporary circulatory enhancement is the same as in the predicate ResQPOD CE devices.

The ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.

The modified ResQPOD Circulatory Enhancer (CE) device is mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE reviewed and cleared for market in 510(k) K022906. This 510(k) submission was provided to review the following feature additions: a) The addition of timing assist lights as a convenience to encourage proper inspiration rate through the ResQPOD CE; b) Modified labeling to support use of the ResQPOD CE on alternative adjunctive airway devices, such as a mouthpiece, facemask with an ISO standard 22 mm connector, and endotracheal tube; c) Provision for an ISO standard 15 mm to 22 mm adapter connector between the ResOPOD CE and the mouthpiece or facemask; and d) Modified labeling to support use of the ResOPOD CE in clinic and emergency care locations with patients who, in the judgment of a physician or licensed professional, may need circulatory enhancement as provided by the ResQPOD CE.