Cleared Special

Therm-X (K231912) - FDA 510(k) Clearance

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

K231912 · Zenith Technical Innovations · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
28d
Days
Class 2
Risk

K231912 is an FDA 510(k) clearance for the Therm-X. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Zenith Technical Innovations (Gurnee, US). The FDA issued a Cleared decision on July 27, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zenith Technical Innovations devices

Submission Details

510(k) Number K231912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2023
Decision Date July 27, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 - IRP Massager, Powered Inflatable Tube

All 95
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K231912.
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