# Headsafe US INC (other, Lake Mary, FL): 2 new FDA device listings, incl. reduced- montage standard electroencephalograph

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | Headsafe US INC |
| Owner / operator | Headsafe US Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Lake Mary, FL, US |
| New listings | 2 |
| Devices | Reduced- Montage Standard Electroencephalograph; Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Product codes | OMC, PIW |
| Device classes | Class II |
| Medical specialties | Neurology |
| Brand names | Nurochek-Pro System; Nurochek-Pro |
| First new listing | 2026-08-25 |
| Latest new listing | 2026-08-25 |
| FDA registration number | 3048720912 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.