Cleared Special

K260076 - SAM 3.0 Multi-Hour Continuous Ultrasound Device

K260076 is an FDA 510(k) clearance for SAM 3.0 Multi-Hour Continuous Ultrasoun..., manufactured by ZetrOZ Systems, LLC. The device is a Class 2 Physical Medicine device with product code PFW cleared through the Special 510(k) pathway after a 106-day FDA review.

K260076 · ZetrOZ Systems, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
106d
Days
Class 2
Risk

K260076 is an FDA 510(k) clearance for the SAM 3.0 Multi-Hour Continuous Ultrasound Device. Classified as Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (product code PFW), Class II - Special Controls.

Submitted by ZetrOZ Systems, LLC (Trumbull, US). The FDA issued a Cleared decision on April 28, 2026 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260076

510(k) Number K260076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2026
Decision Date April 28, 2026
Days to Decision 106 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 116d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

PFW Device Classification - Class 2, Special Controls

Product Code PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
Definition Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

All 8
Devices cleared under the same product code (PFW) and FDA review panel - the closest regulatory comparables to K260076.
sam CS Long Duration Ultrasound Device
K233210 · ZetrOZ Systems, LLC · Oct 2023
sam 2.0 Long Ultrasound Device
K223019 · ZetrOZ Systems, LLC · Jun 2023
PainShield MD PLUS
K221210 · Nanovibronix, Inc. · Nov 2022
sam X1 Long Duration Ultrasound Device
K211513 · ZetrOZ Systems, LLC · Aug 2021
sam 2.0 Long Duration Ultrasound System
K191568 · ZetrOZ Systems, LLC · Mar 2020
ZTX ULTRASONIC DIATHERMY DEVICE
K130978 · Zetroz, Inc. · Nov 2013
K260076 · SAM 3.0 Multi-Hour Continuous Ultrasound Device
Download PDF FDA Summary ZetrOZ Systems, LLC