Data / Medical devices / United States / Universal Brain Inc.
Universal Brain Inc.: FDA-registered device maker in Palo Alto, CA, United States, 1 510(k) clearance
Universal Brain Inc. is registered with the FDA (registration 3038896098) in Palo Alto, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038896098
- Address
- Homer Ave, Palo Alto, CA, United States, 94301
- Owner or operator
- Universal Brain Inc. (10093432)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 19, 2026
- Registered through
- 2026
- Brand names listed
- UB ERP System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 30, 2026 | K253767 | UB ERP System | OLT | Substantially Equivalent | Universal Brain | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Full-Montage Standard Electroencephalograph
Updated June 30, 2026. 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.