| K-number | K243199 |
| Device name | NightWatch+ US |
| Applicant | Livassured BV |
| Product code | POS |
| Device class | Class II |
| Decision date | Jul 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.1580 |
The NightWatch+ US is a wearable seizure monitoring system for children aged 4-16 with epilepsy. It consists of an upper-arm sensor measuring heart rate (via photoplethysmography) and motion data, paired with a wireless alarm station that alerts caregivers when nocturnal epileptic motor seizures are detected. Data is stored in a cloud portal for review. The device is prescription-only and indicated for home or residential use during sleep.
The device uses PPG (photoplethysmography) and accelerometer sensors, whereas the predicate Embrace uses electrodermal activity (EDA) and accelerometer sensors. Both communicate wirelessly to a caregiver notification device, employ rechargeable lithium-ion batteries, and use algorithms to detect seizure patterns. NightWatch+ US is worn on the upper arm; Embrace on the wrist. Both meet IEC 60601-1 electrical safety and IEC 60601-1-2 EMC standards.
IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety); IEC 60601-1-2:2014+A1:2020 (EMC); IEC 60601-1-6, 60601-1-8, 60601-1-11 (collateral standards); ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 (biocompatibility); 47 CFR Part 15 (FCC unintentional radiators); ETSI EN 301 489-1 and 489-6 (EMC for radio equipment).
Both devices are non-EEG physiological signal-based seizure monitoring systems in the same Class II product code (POS), intended as adjuncts for home seizure monitoring in pediatric epilepsy patients. Although NightWatch+ US uses different sensors (PPG+accelerometer vs. EDA+accelerometer+temperature) and notifies via alarm station rather than smartphone app, the clinical study (van Westrhenen et al. 2023) demonstrates equivalent performance: 89-94% sensitivity for nocturnal epileptic major motor seizures with 0.06/hour false alarm rate, matching the predicate's 96.9% TC sensitivity and 0.06/hour FAR. The differences in sensor technology, wear location, and notification method do not raise new safety or effectiveness concerns given both devices meet the same electrical and biocompatibility standards and achieve comparable seizure detection performance in their respective populations.
View the full FDA submission: accessdata.fda.gov