Cleared Traditional

K171685 - Med4 Elite

K171685 is an FDA 510(k) clearance for Med4 Elite, manufactured by Cool Systems, Inc. (Dba Game Ready). The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K171685 · Cool Systems, Inc. (Dba Game Ready) · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
114d
Days
Class 2
Risk

K171685 is an FDA 510(k) clearance for the Med4 Elite. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Cool Systems, Inc. (Dba Game Ready) (Concord, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 114 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 Cool Systems, Inc. (Dba Game Ready) devices

FDA 510(k) Submission Details - K171685

510(k) Number K171685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2017
Decision Date September 29, 2017
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

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 101
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K171685.
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