Device typeNon-rechargeable public semi-automated external defibrillator: A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.
FDA categoryOver-The-Counter Automated External Defibrillator
Device ID00884838075849
Catalog numberM5066A
AvailabilityOver the counter
MRI safetyMR Unsafe