510(k) · Cleared
Recalled · 2011Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coolsystems, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Jun 29, 2007 as substantially equivalent to K951769 (Grimm Scientific Industries, Inc., 1995) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1995. 25 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- IRP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951769 (1995). 2 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951769 CryopressGrimm Scientific Industries, Inc. · 1995
- This deviceK071050 Game Ready Professional Therapy System, Model 550100, Game Ready…Coolsystems, Inc. · 2007
- Descendant · cites it directly · 23 of its ownK072620 Game Ready Classic System, Model 550550Coolsystems, Inc. · 2007
- Descendant · 2 generations on · 21 of its ownK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
- Descendant · 2 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- Descendant · 3 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
- Descendant · 3 generations on · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K072620Game Ready Classic System, Model 550550Coolsystems, Inc. · 2007 · cites it directly23descendants
- K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017 · 2 generations on21descendants
- K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 2 generations on12descendants
- K190854Therm-XZenith Technical Innovations · 2019 · 3 generations on11descendants
- K193550Therm-XZenith Technical Innovations · 2020 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951769 | Cryopress | Grimm Scientific Industries, Inc. | 1995 | — |
| 0 (this device) | K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready… | Coolsystems, Inc. | 2007 | — |
| +1 | K072620 | Game Ready Classic System, Model 550550 | Coolsystems, Inc. | 2007 | — |
| +2 | K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 | — |
| +2 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| +3 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| +3 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IRP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951769 | CryopressSummary page 1…y System is substantially equivalent to the following predicate devices: Device, K# Manufacturer Product Code(s) CRYOPress, K951769 Grimm Scientific ILO/IRP Polar Care 500, K961855 Breg, Inc. ILO D. Device Descriptio… | 1995 |
| * | K961855 | Polar Care (Model 500/50000)Summary page 1…: Device, K# Manufacturer Product Code(s) CRYOPress, K951769 Grimm Scientific ILO/IRP Polar Care 500, K961855 Breg, Inc. ILO D. Device Description: The Game Ready System is comprised of the following components: *… | 1996 |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2011 | Not classified | Z-3210-2011 | Employee error | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K072620 (Coolsystems, Inc., 2007) has gone furthest, with 23 descendants of its own.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
The Game Ready System combines cold and compression therapies. It is intended to
treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and
compression are indicated. It is intended to be used by or on the order of healthcare
professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071050: Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071050
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026