K260076
- 510(k) number
- K260076
- Device name
- SAM 3.0 Multi-Hour Continuous Ultrasound Device
- Applicant
- ZetrOZ Systems, LLC CT · US
- Product code
- PFW — Stationary Ultrasonic Diathermy Device For Use In Ap
- Decision date
- 2026-04-28
- Date received
- 2026-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260076.pdf
Official FDA record: K260076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.