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FDA PRODUCT CODE · CLASS II

POS — Physiological Signal Based Seizure Monitoring System

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1580
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K251506Neuro Event Labs OY · 510k2025-11-21
K243199Livassured BV · 510k2025-07-12
K250515Empatica S.r.l. · 510k2025-06-19
K243515Epiwatch, Inc. · 510k2025-03-07

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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