(a)Identification. An automated external defibrillator (AED) is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. An AED analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
(b)Classification. Class III (premarket approval)
(c)Date PMA or notice of PDP is required. No effective date has been established of the requirement for premarket approval. See 870.3.
[68 FR 61344, Oct. 28, 2003; 69 FR 10615, Mar. 8, 2004]