SAM 3.0 Multi-Hour Continuous Ultrasound Device— 510(k) K260076

Name: FDA 510(k) clearance K260076
Creator: U.S. Food and Drug Administration
Published: 2026-04-28

Substantially Equivalent

ZetrOZ Systems, LLC

FDA 510(k) clearance K260076 for SAM 3.0 Multi-Hour Continuous Ultrasound Device, Substantially Equivalent on 2026-04-28. Applicant: ZetrOZ Systems, LLC. Device class: 2.

Summary

ZetrOZ Systems' SAM 3.0 Multi-Hour Continuous Ultrasound Device is filed under product code PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat).

Class II, 21 CFR 890.5300. Physical Medicine is both the classification panel and the review panel. It came in as a Special 510(k).

ZetrOZ Systems filed from Trumbull, Connecticut. The record shows 106 calendar days from receipt to decision (January 12 to April 28, 2026).

Clearance details

Applicant: ZetrOZ Systems, LLC
Product code: Product code PFW
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2026-01-12
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Trumbull, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PFW

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K233210 — sam CS Long Duration Ultrasound Device2023-10-25
K223019 — sam 2.0 Long Ultrasound Device2023-06-23
K221210 — PainShield MD PLUS2022-11-23
K211513 — sam X1 Long Duration Ultrasound Device2021-08-18
K191568 — sam 2.0 Long Duration Ultrasound System2020-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.