510(k) K243131 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Triathlon Pro
| Applicant | Sigma Biomedical, Sunrise FL, US |
| Decision | Substantially Equivalent, Nov 7, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243131
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.