Cleared Traditional

K223019 - sam 2.0 Long Ultrasound Device (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223019 · ZetrOZ Systems, LLC · Physical Medicine device
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Jun 2023
Decision
267d
Days
Class 2
Risk

K223019 is an FDA 510(k) clearance for the sam 2.0 Long 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 June 23, 2023 after a review of 267 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all ZetrOZ Systems, LLC devices

Submission Details

510(k) Number K223019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date June 23, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 115d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K223019.
SAM 3.0 Multi-Hour Continuous Ultrasound Device
K260076 · ZetrOZ Systems, LLC · Apr 2026
sam CS Long Duration Ultrasound Device
K233210 · ZetrOZ Systems, LLC · Oct 2023
PainShield MD PLUS
K221210 · Nanovibronix, Inc. · Nov 2022
sam X1 Long Duration Ultrasound Device
K211513 · ZetrOZ Systems, LLC · Aug 2021