510(k) K253536 ยท ETN Stimulator, Nerve
Evala Nerve Stimulator (EPNR002)
| Applicant | Epineuron Technologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Feb 27, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253536
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.