Cleared Traditional

K181149 - Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (FDA 510(k) Clearance)

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

K181149 · Zenith Technical Innovations · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
94d
Days
Class 2
Risk

K181149 is an FDA 510(k) clearance for the Therm-X Pro, Therm-X AT, Therm-X Pro Athlete. 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 August 3, 2018 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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 Zenith Technical Innovations devices

Submission Details

510(k) Number K181149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2018
Decision Date August 03, 2018
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K181149.
Air Pressure Therapy System (VU-IPC8M)
K253064 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Apr 2026
Hot and Cold Compression System (A02-C-032)
K252386 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Cryopush Cold Compression Device (A02-P-001)
K253076 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Hand Massager (SM004D)
K251622 · Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Jan 2026
Air Compression Therapy Device (ST-504)
K251662 · Shenzhen Future Electronic Co., Ltd. · Nov 2025
AIR COMPRESSION BOOTS 1018195,1018196
K251531 · Merchsource, LLC · Oct 2025