POS — Physiological Signal Based Seizure Monitoring System Class II
FDA product code POS covers "Physiological Signal Based Seizure Monitoring System", a Class II medical device regulated under 21 CFR 882.1580. Submissions are reviewed by the Neurology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- POS
- Device Class
- Class II
- Regulation Number
- 882.1580
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251506 | neuro event labs | Nelli (Version 7.11) | November 21, 2025 |
| K243199 | livassured | NightWatch+ US | July 12, 2025 |
| K250515 | empatica | EpiMonitor | June 19, 2025 |
| K243515 | epiwatch | EpiWatch Monitoring System | March 7, 2025 |
| K232915 | empatica | EpiMonitor | February 15, 2024 |
| K200276 | brain sentinel | SPEAC System | February 6, 2021 |
| K182180 | brain sentinel | SPEAC System | May 11, 2019 |
| K181861 | empatica | Embrace | December 20, 2018 |
| K172935 | empatica | Embrace | January 26, 2018 |
| DEN140033 | lgch | Companion | February 16, 2017 |