Game Ready GRPro 2.1 System
by Cool Systems, Inc. (Dba Game Ready)
510(k) K192114
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192114 | Date29 Oct 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
The Game Ready GRPro 2.1 System is a powered inflatable tube massager designed for active cold therapy and intermittent pneumatic compression. It integrates circumferential wraps with a control unit to deliver simultaneous cold and compression treatments, targeting swelling, muscle spasms, and postoperative pain.
This device is intended for use in clinical settings, providing single-use or reusable wraps depending on the model. It operates with MRI-safe components and is supplied with various sizes of inflatable tubes. The system holds FDA 510(k) clearance under the Physical Medicine advisory committee and is regulated under 21 CFR 890.5650.
Other devices from Cool Systems, Inc. (Dba Game Ready)
Questions
AI-generated answers, 20 Sep 2026
What clinical conditions is the Game Ready GRPro 2.1 System primarily designed to address?
The Game Ready GRPro 2.1 System is designed to target swelling, muscle spasms, and postoperative pain through combined active cold therapy and intermittent pneumatic compression. It uses circumferential wraps and a control unit to deliver simultaneous treatment, making it suitable for clinical settings where these conditions are common.
Are the wraps for the Game Ready GRPro 2.1 System single-use or reusable, and how does this affect my purchasing decision?
The Game Ready GRPro 2.1 System offers both single-use and reusable wraps, depending on the model selected. Single-use wraps are ideal for reducing infection risk in clinical settings where patient isolation is critical, while reusable wraps can lower costs over time for facilities with high usage. Check the specific model documentation to confirm which option aligns with your workflow and hygiene protocols.
Does the Game Ready GRPro 2.1 System include MRI-safe components, and what does this mean for my facility?
Yes, the Game Ready GRPro 2.1 System is designed with MRI-safe components, meaning it can be safely used in areas where MRI scans are performed without interfering with imaging or posing risks to patients. This is particularly useful in orthopedic or sports medicine clinics where patients may require both therapy and imaging.
What sizes of inflatable tubes are available for the Game Ready GRPro 2.1 System, and how do I determine the right fit for a patient?
The Game Ready GRPro 2.1 System is supplied with multiple sizes of inflatable tubes to accommodate different anatomical regions, though exact measurements are not specified in the provided data. To determine the correct size, refer to the manufacturer’s sizing guide or consult with a healthcare professional familiar with the device’s application. Proper sizing ensures effective compression and therapy delivery.
How is the Game Ready GRPro 2.1 System regulated, and what does this mean for compliance in my facility?
The Game Ready GRPro 2.1 System holds FDA 510(k) clearance under the Physical Medicine advisory committee, classified under 21 CFR 890.5650. This means it meets U.S. regulatory standards for powered inflatable tube massagers and is considered substantially equivalent to a predicate device. Facilities using it must ensure compliance with FDA guidelines for its intended clinical use and maintenance protocols.