Data / Medical devices / Physiological Signal Based Seizure Monitoring System
Physiological Signal Based Seizure Monitoring System (POS): 6 FDA-registered makers in 5 countries
6 establishments in 5 countries are registered with the FDA to make Physiological Signal Based Seizure Monitoring System (product code POS, Class 2, 21 CFR 882.1580). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on November 21, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- POS
- Device class
- 2
- Regulation
- 882.1580
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Italy | 1 |
| Netherlands | 1 |
| Finland | 1 |
| South Korea | 1 |
Makers of Physiological Signal Based Seizure Monitoring System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| EMPATICA S.r.l. | Milano, Italy | Complaint file establishment, Manufacturer, Specification developer | 4 | June 19, 2025 | 0 | 1 | 0 | api.fda.gov |
| EpiWatch, Inc. | Baltimore, MD, United States | Manufacturer | 1 | March 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Livassured | Leiden Zuid-Holland, Netherlands | Specification developer | 1 | July 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Neuro Event Labs OY | Tampere Pirkanmaa, Finland | Manufacturer | 1 | November 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intops Co.,ltd. | Suwon Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Medx LLC | Cary, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.