Cleared Traditional

K192114 - Game Ready GRPro 2.1 System

K192114 is the FDA 510(k) clearance for Game Ready GRPro 2.1 System by Cool Systems, Inc. (Dba Game Ready). It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K192114 · Cool Systems, Inc. (Dba Game Ready) · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
84d
Days
Class 2
Risk

K192114 is an FDA 510(k) clearance for the Game Ready GRPro 2.1 System. 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 October 29, 2019 after a review of 84 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 Cool Systems, Inc. (Dba Game Ready) devices

Submission Details

510(k) Number K192114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2019
Decision Date October 29, 2019
Days to Decision 84 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
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 Consultant

Njk & Associates
Natalie Kennel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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