Cleared Traditional

K130978 - ZTX ULTRASONIC DIATHERMY DEVICE (FDA 510(k) Clearance)

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

K130978 · Zetroz, Inc. · Physical Medicine device
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Nov 2013
Decision
211d
Days
Class 2
Risk

K130978 is an FDA 510(k) clearance for the ZTX ULTRASONIC DIATHERMY DEVICE. Classified as Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (product code PFW), Class II - Special Controls.

Submitted by Zetroz, Inc. (Trumbull, US). The FDA issued a Cleared decision on November 6, 2013 after a review of 211 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, Inc. devices

Submission Details

510(k) Number K130978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2013
Decision Date November 06, 2013
Days to Decision 211 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
96d slower than avg
Panel avg: 115d · This submission: 211d
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
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