510(k) K260076 ยท PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
SAM 3.0 Multi-Hour Continuous Ultrasound Device
| Applicant | ZetrOZ Systems, LLC, Trumbull CT, US |
| Decision | Substantially Equivalent, Apr 28, 2026 |
| Received | Jan 12, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260076
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.