Details
Device typeHome seizure monitoring system: An assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.
FDA categoryPhysiological Signal Based Seizure Monitoring System
Device ID00853858006133
Catalog numberEM2-FP-S
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information