Headsafe US INC (other, Lake Mary, FL): 2 new FDA device listings, incl. reduced- montage standard electroencephalograph
Headsafe US INC (Lake Mary, Florida): 2 new FDA device listings, incl. reduced- montage standard electroencephalograph. Its amount of 2 is above the median of 1 (69th percentile). Dated 71 days ago, it serves as a historical benchmark. Score 50/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 83 related FL DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (84 FL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-25
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Headsafe US INC and 84 Florida peers
- Florida DeviceEstablishmentPulse records like this one: 84
- Headsafe US INC's amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $16,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
50 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Headsafe US INC in Lake Mary, Florida?
Headsafe US INC (Lake Mary, FL), a other, added 2 FDA device listings on 2026-08-25.
How does Headsafe US INC compare to other Florida DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 71 days old; check the official source for later updates before acting.
Headsafe US INC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Headsafe US INC | Lake Mary, FL | 2 | 69th | 2026-08-25 |
| Metier Medical (USA) LLC | Ponte Vedra Beach, FL | 7 | 90th | 2026-10-16 |
| Advance-Esthetic LLC | Fort Lauderdale, FL | 8 | 91st | 2026-10-12 |
| Ortho Max Inc | Palm City, FL | 14 | 96th | 2026-08-26 |
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DeviceEstablishmentPulse: Other DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Florida
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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.