4 devices · 2 companies · 2018 to 2025
Product code POS: Physiological Signal Based Seizure Monitoring System
4 devices under product code POS, 2018 to 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Physiological Signal Based Seizure Monitoring System. 21 CFR 882.1580, Class II. The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device. MAUDE held 4 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| NelliK251506 · 510(k) | Neuro Event Labs OY | Neurology | database entry | |
| EpiMonitorK250515 · 510(k) | Empatica Srl | Neurology | database entry | |
| EpiMonitorK232915 · 510(k) | Empatica Srl | Neurology | database entry | |
| EmbraceK181861 · 510(k) | Empatica Srl | Neurology | database entry |
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