Device typeWearable defibrillation system defibrillator: A portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm.
FDA categoryWearable Automated External Defibrillator
Device ID00840241600153
Catalog number80016-004
AvailabilityPrescription
Single useYes
MRI safetyMR Unsafe
SizeStyle B, Size 4