Cleared Special

K211513 - sam X1 Long Duration Ultrasound Device (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211513 · ZetrOZ Systems, LLC · Physical Medicine device
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Aug 2021
Decision
96d
Days
Class 2
Risk

K211513 is an FDA 510(k) clearance for the sam X1 Long Duration 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 August 18, 2021 after a review of 96 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.

View all ZetrOZ Systems, LLC devices

Submission Details

510(k) Number K211513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2021
Decision Date August 18, 2021
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

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 K211513.
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
sam 2.0 Long Ultrasound Device
K223019 · ZetrOZ Systems, LLC · Jun 2023
PainShield MD PLUS
K221210 · Nanovibronix, Inc. · Nov 2022