510(k) K243279 ยท PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
DOLORCLAST Focused Shock Waves
| Applicant | E.M.S Electro Medical Systems S.A, Nyon, CH |
| Decision | Substantially Equivalent, Aug 13, 2025 |
| Received | Oct 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243279
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.