Data / Medical devices / Canada / Epineuron Technologies Inc.
Epineuron Technologies Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 1 510(k) clearance
Epineuron Technologies Inc. is registered with the FDA (registration 3026023106) in Mississauga Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026023106
- Address
- 1875 Buckhorn Gate Suite 602, Mississauga Ontario, Canada, L4W 5P1
- Owner or operator
- Epineuron Technologies Inc. (10087337)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 2, 2026
- Registered through
- 2026
- Brand names listed
- Evala
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve | ETN | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 27, 2026 | K253536 | Evala Nerve Stimulator (EPNR002) | ETN | Substantially Equivalent | Epineuron Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 27, 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.