Cleared Traditional

K072620 - GAME READY CLASSIC SYSTEM, MODEL 550550

K072620 is an FDA 510(k) clearance for GAME READY CLASSIC SYSTEM, manufactured by Coolsystems, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K072620 · Coolsystems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
44d
Days
Class 2
Risk

K072620 is an FDA 510(k) clearance for the GAME READY CLASSIC SYSTEM, MODEL 550550. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Coolsystems, Inc. (Berkeley, US). The FDA issued a Cleared decision on October 31, 2007 after a review of 44 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coolsystems, Inc. devices

FDA 510(k) Submission Details - K072620

510(k) Number K072620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date October 31, 2007
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 113
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