Device class
Class II
Regulation 882.1580
Total clearances
6
2021-02-06 → 2025-11-21
Definition
What is 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.
Classification details
Medical specialty
Neurology
Regulation number
882.1580
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Empatica S.r.l.
|
2 |
0 |
2025-06-19 |
|
Brain Sentinel, Inc. |
1 |
0 |
2021-02-06 |
|
Livassured BV |
1 |
0 |
2025-07-12 |
|
Epiwatch, Inc. |
1 |
0 |
2025-03-07 |
|
Neuro Event Labs OY |
1 |
1 |
2025-11-21 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 95950 |
CPT
|
— |
High
|
EEG; recording only (includes hyperventilation and photic stimulation when performed) |
| 95951 |
CPT
|
— |
High
|
EEG; electrode placement and monitoring; each electrode |
Pulse
Most recent 510(k) clearances