Data / Medical devices / United States / Epiminder America Inc
Epiminder America Inc: FDA-registered device maker in Irving, TX, United States, 1 510(k) clearance
Epiminder America Inc is registered with the FDA (registration 3039640505) in Irving, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039640505
- Address
- 4545 Fuller Dr Ste 225, Irving, TX, United States, 75038
- Owner or operator
- Epiminder Limited (10093773)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- July 8, 2025
- Registered through
- 2026
- Brand names listed
- Minder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | SEM | 2 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 17, 2025 | DEN240062 | Minder System | SEM | Unknown | Epi-Minder Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 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.