EpiMonitor

EpiMonitor is a wearable medical device system composed of the EmbracePlus wristband and paired mobile app intended to detect generalized tonic-clonic seizures in adults and children aged 6+ in home and healthcare settings. The wristband continuously monitors electrodermal activity (EDA) and motion data, analyzes them via an on-board algorithm, and alerts designated caregivers via voice call or SMS when a likely seizure is detected. The system also records physiological data for retrospective review by healthcare providers through a cloud-based portal.

EpiMonitor uses the same EpiAlgo 2.1 seizure detection algorithm, same product codes (POS, LEL, FLL), same indication for use, and identical wireless communication (Bluetooth Low Energy to mobile device; WiFi/cellular to cloud) as the predicate K232915. The primary difference is EDA sensor location (dorsal vs. ventral wrist) and band material (Elastane/Polyamide vs. Silicone Rubber), but both devices use rechargeable lithium-ion batteries, house identical materials compliant with ISO 10993-1, and target the same population in the same environments.

ISO 10993-1 (biocompatibility of patient-contacting materials); FDA Guidance on Radio Frequency Wireless Technology in Medical Devices (August 2013); FDA Guidance on Content of Premarket Submissions for Device Software Functions; FDA Guidance on Cybersecurity in Medical Devices.

Substantial equivalence is supported by identical intended use, indications, algorithm, product codes, and patient population as the predicate K232915. Bench testing demonstrated equivalent electrodermal activity measurement and algorithm performance using simulated seizure patterns. The sole design change—dorsal EDA sensor placement instead of ventral—was verified through testing to not raise new safety or efficacy questions. Software verification and validation, cybersecurity assessment, and clinical performance analysis using Low-Sensitivity mode (new feature) on real-world and EMU data confirmed acceptable seizure detection accuracy and reduced false alarm rates without adverse findings.