Data / Medical devices / United States / Headsafe US INC
Headsafe US INC: FDA-registered device maker in Lake Mary, FL, United States, 1 510(k) clearance
Headsafe US INC is registered with the FDA (registration 3048720912) in Lake Mary, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3048720912
- Address
- 1011 Shadowmoss Cir, Lake Mary, FL, United States, 32746
- Owner or operator
- Headsafe US Inc. (10096296)
- Roles
- Complaint file establishment
- First device listed
- August 25, 2026
- Registered through
- 2026
- Brand names listed
- Nurochek-Pro, Nurochek-Pro System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | PIW | 2 | Complaint file establishment | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2025 | K243426 | Nurochek-Pro System | PIW | Substantially Equivalent | Headsafe Mfg Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 27, 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.