Cleared Traditional

GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM (K071050) - FDA 510(k) Clearance

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

K071050 · Coolsystems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
77d
Days
Class 2
Risk

K071050 is an FDA 510(k) clearance for the GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMM.... 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 June 29, 2007 after a review of 77 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

Submission Details

510(k) Number K071050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2007
Decision Date June 29, 2007
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 151
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