510(k) · Cleared
ClearedMed4 Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cool Systems, Inc. (Dba Game Ready) · IRP Massager, Powered Inflatable Tube
Cleared on Sep 29, 2017 as substantially equivalent to K072620 (Coolsystems, Inc., 2007) and 1 other predicate after a 114-day review. Its family tree reaches back 3 generations to 1995. 21 later devices descend from it.
- Decided
- Sep 29, 2017
- Review
- 114 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944567 (1995). 12 ancestors in all, the oldest K942796 (1995). 21 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 2 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 1 generation backK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- This deviceK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
- Descendant · cites it directly · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- Descendant · cites it directly · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
- Descendant · 2 generations on · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020
- Descendant · 3 generations on · 3 of its ownK223729 FLOWpressoMedella Health Limited · 2023
- Descendant · cites it directly · 3 of its ownK183702 Polar Care WaveBreg, Inc. · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · cites it directly12descendants
- K190854Therm-XZenith Technical Innovations · 2019 · cites it directly11descendants
- K193550Therm-XZenith Technical Innovations · 2020 · 2 generations on10descendants
- K223729FLOWpressoMedella Health Limited · 2023 · 3 generations on3descendants
- K183702Polar Care WaveBreg, Inc. · 2019 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −2 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −1 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| 0 (this device) | K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 | — |
| +1 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| +1 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| +2 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| +3 | K223729 | FLOWpresso | Medella Health Limited | 2023 | — |
| +1 | K183702 | Polar Care Wave | Breg, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K072620 | Game Ready Classic System, Model 550550Summary page 4…nel 89- Physical Medicine Predicate Devices The predicate devices are listed in Table 1. The primary predicate device is the Game Ready® Classic System (GR2) (K072620) and the secondary predicate is the VascuTherm™ (K061866). One other reference device is also listed. None of the predicates have… | 2007 |
| * | K061866 | Nanotherm, Vascutherm and Prothermo Therapy WrapsSummary page 4…e predicate devices are listed in Table 1. The primary predicate device is the Game Ready® Classic System (GR2) (K072620) and the secondary predicate is the VascuTherm™ (K061866). One other reference device is also listed. None of the predicates have been subject to design recalls. Game Ready Med4 Elite™… | 2006 |
| † | K964799 | Artrotherm Cryotherapy and Thernotherapy | 1997 |
What descends from it? (21)
See all 218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | 2018 | 12 |
| K190854 | Therm-X | 2019 | 11 |
| K183702 | Polar Care Wave | 2019 | 3 |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | 2025 | 1 |
| K252396 | Cryo Sport 2.0 (AVA 501) | 2026 | 0 |
| K252386 | Hot and Cold Compression System (A02-C-032) | 2026 | 0 |
| K222136 | Cryo-Thermo Compression Device (FGK002) | 2023 | 0 |
| K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE Systems | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K181149 (Zenith Technical Innovations, 2018) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K072620.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Med4 Elite™ combines cold, heat, contrast and compression therapies.
It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated.
It is intended to treat post traumatic and post surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171685: Med4 Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171685
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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