Physiological Signal Based Seizure Monitoring System
The Physiological Signal Based Seizure Monitoring System (product code POS) is a Class 2 neurology prescription device that uses physiological signals to identify abnormal physiological activity that may be associated with a seizure, regulated under 882.1580. The system does not predict seizure onsets and is not intended as a standalone seizure monitoring device. It requires 510(k) clearance and is not an implant or life-sustaining product.
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Basic Information
- Product Code
- POS
- Device Class
- FDA class 2
- Regulation Number
- 882.1580
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251506 | Nelli (Version 7.11) | Nov 21, 2025 | Substantially Equivalent | Neuro Event Labs OY |
| K243199 | NightWatch+ US | Jul 12, 2025 | Substantially Equivalent | Livassured BV |
| K250515 | EpiMonitor | Jun 19, 2025 | Substantially Equivalent | Empatica S.r.l. |
| K243515 | EpiWatch Monitoring System | Mar 07, 2025 | Substantially Equivalent | Epiwatch, Inc. |
| K232915 | EpiMonitor | Feb 15, 2024 | Substantially Equivalent | Empatica S.r.l. |
| K200276 | SPEAC System | Feb 06, 2021 | Substantially Equivalent | Brain Sentinel, Inc. |
| K182180 | SPEAC System | May 11, 2019 | Substantially Equivalent | Brain Sentinel, Inc. |
| K181861 | Embrace | Dec 20, 2018 | Substantially Equivalent | Empatica S.r.l. |
| K172935 | Embrace | Jan 26, 2018 | Substantially Equivalent | Empatica S.r.l. |
| DEN140033 | Companion | Feb 16, 2017 | Unknown | Lgch, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.