Does the ResQPOD Circulatory Enhancer have 510(k) clearance from the FDA?
Yes; 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. It is contraindicated in dilated cardiomyopathy, congestive heart failure, pulmonary hypertension, aortic stenosis, flail chest, chest pain and shortness of breath. It can be used with a facemask, endotracheal tube or other appropriate airway adjunct used for assisted ventilation. The ResQPOD Circulatory Enhancer can be used in patients requiring assisted ventilation, for example, patients receiving CPR.
Related Questions
- Has the ResQPOD Circulatory Enhancer been tested with semi-open anesthetic circuits (e.g. Bain, McGill, Lack) as these are used in emergency resuscitation rooms connected to resuscitation machines?
- Has the ResQPOD Circulatory Enhancer been tested with Soda Lime Absorber Closed Circuit anesthetic systems, which are also used in resuscitation areas?
- Does the ResQPOD Circulatory Enhancer have 510(k) clearance from the FDA?
