Cleared Abbreviated

Therm-X (K190854) - FDA 510(k) Clearance

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

K190854 · Zenith Technical Innovations · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
38d
Days
Class 2
Risk

K190854 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 May 10, 2019 after a review of 38 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zenith Technical Innovations devices

Submission Details

510(k) Number K190854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2019
Decision Date May 10, 2019
Days to Decision 38 days
Submission Type Abbreviated
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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Standards-based clearance path.

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 Consultant

MethodSense, Inc.
Rita King

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

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