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Physiological Signal Based Seizure Monitoring System

FDA product code POS · Class 2 · Neurology

28
Registered devices
4
Adverse events
1
Recalls
10
510(k) clearances

Devices with this code

Embrace2 — EMPATICA SRLEpiMonitor — EMPATICA SRLSPEAC System Electrode Patch-SPC15-900431 — BRAIN SENTINEL, INC.SPEAC System Electrode Patch SPC15-90044, EU — BRAIN SENTINEL, INC.Embrace2 — EMPATICA SRLNightWatch+ US — Livassured B.V.Embrace2 — EMPATICA SRLSPEAC System Electrode Patch SPC15-90018 — BRAIN SENTINEL, INC.Embrace2 — EMPATICA SRLAccuSense Sensitive Electrode Patch SPC15-90055 EU — BRAIN SENTINEL, INC.Embrace2 — EMPATICA SRLEpiMonitor — EMPATICA SRLSPEAC System Electrode Patch SPC15-90018 — BRAIN SENTINEL, INC.Embrace2 — EMPATICA SRLSPEAC System Electrode Patch-SPC15-90045, EU — BRAIN SENTINEL, INC.SPEAC System Electrode Patch SPC15-90044, EU — BRAIN SENTINEL, INC.EpiWatch — Epiwatch, Inc.SPEAC System Assy, Mini Monitor, EU — BRAIN SENTINEL, INC.SPEAC System Assy, Mini Monitor, US — BRAIN SENTINEL, INC.SPEAC System — BRAIN SENTINEL, INC.SPEAC System Electrode Patch-SPC15-90045, EU — BRAIN SENTINEL, INC.Embrace2 — EMPATICA SRLEmbrace2 — EMPATICA SRLEmbrace2 — EMPATICA SRL

Recent recalls

DateFirmReason
2023-07-13EMPATICA SRLMay have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.