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Game Ready Professional Therapy System Model 550100

by Coolsystems, Inc.

510(k) K071050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071050 Date29 Jun 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3210-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2011

    It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System
510(k) Number
FDA Product Code
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Game Ready Professional Therapy System Model 550100 is a Powered Inflatable Tube Massager, designed for physical medicine applications. It delivers controlled, intermittent pneumatic compression to promote circulation, reduce swelling, and aid in recovery following orthopedic injuries or surgical procedures.

This device is intended for professional use in clinical settings and is supplied as a reusable system. It operates under 21 CFR 890.5650 and has received FDA 510K clearance as substantially equivalent to predicate devices. The system includes pre-programmed therapy protocols and is classified as a Class II medical device under the IRP product code.

Other devices from Coolsystems, Inc.

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical applications is the Game Ready Professional Therapy System primarily designed for?

    The Game Ready Professional Therapy System Model 550100 is designed for physical medicine applications, specifically to deliver controlled, intermittent pneumatic compression. It is intended to promote circulation, reduce swelling, and aid recovery following orthopedic injuries or surgical procedures, making it suitable for clinical settings where post-procedure or injury rehabilitation is required.

  • Is the Game Ready Professional Therapy System reusable or single-use, and how should it be maintained?

    The Game Ready Professional Therapy System is supplied as a reusable device. Since it is intended for professional use, it should be cleaned and maintained according to the manufacturer’s instructions to ensure proper functionality and hygiene. The system’s reusable nature allows for repeated use in clinical settings, provided it is properly serviced and disinfected between patients.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    The Game Ready Professional Therapy System received FDA 510K clearance through a traditional review process, demonstrating it is substantially equivalent to predicate devices under 21 CFR 890.5650. This means the device has undergone FDA evaluation to confirm its safety and effectiveness for its intended professional use in physical medicine, ensuring it meets regulatory standards for powered inflatable tube massagers in clinical settings.

  • Are there pre-programmed therapy protocols included with the Game Ready Professional Therapy System, and how does that benefit users?

    Yes, the Game Ready Professional Therapy System includes pre-programmed therapy protocols tailored for professional use. These protocols simplify operation by providing standardized settings for intermittent pneumatic compression, allowing clinicians to quickly apply evidence-based treatment parameters without manual adjustments. This ensures consistent and effective therapy delivery for patients recovering from orthopedic injuries or surgeries.

  • What types of sizes or configurations are available for the inflatable tubes in this system?

    The device data lists multiple registration numbers (e.g., 3012184077, 3027321925) associated with various inflatable tube configurations, indicating the system supports multiple sizes and models to accommodate different patient needs. While exact dimensions or specific models are not detailed here, the variety suggests flexibility for clinical use, such as upper or lower extremity applications, ensuring compatibility with diverse patient anatomies and treatment requirements.