Cleared Traditional

K153696 - Chattanooga Revolution Wireless

K153696 is an FDA 510(k) clearance for Chattanooga Revolution Wireless, manufactured by Djo, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K153696 · Djo, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
113d
Days
Class 2
Risk

K153696 is an FDA 510(k) clearance for the Chattanooga Revolution Wireless. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Djo, LLC (Vista, US). The FDA issued a Cleared decision on April 14, 2016 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Djo, LLC devices

FDA 510(k) Submission Details - K153696

510(k) Number K153696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date April 14, 2016
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 236
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K153696.
StimSox(TM) System
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FLEX-MT +
K140467 · Emsi · Oct 2014
GEKO
K133638 · Firstkind Limited · Aug 2014
NEURODYN COMPACT, NEURODYN II
K131917 · Ibramed Equipamentos Medicos · Apr 2014