510(k) · Cleared
ClearedCryo And Thermo Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Weiyou Intelligent Technology Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Jun 10, 2026 as substantially equivalent to K242754 (Zamar Medical D.O.O., 2025) after a 184-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 10, 2026
- Review
- 184 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944567 (1995). 14 ancestors in all, the oldest K942796 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 4 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 3 generations backK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- 2 generations backK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
- 1 generation backK242754 ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O. · 2025
- This deviceK253919 Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −4 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −3 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| −2 | K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 | — |
| −1 | K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | 2025 | — |
| 0 (this device) | K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Summary page 5…red inflatable tube massager Classification name: Massager, Powered Inflatable Tube Regulation Number: 890.5650 Product Code: IRP, ILO Legally Marketed Predicate Deice K242754 Z-ONE, ZT Cube (ZC3), ZT Clinic ZAMAR Medical d.o.o. 2. Device Description AC-powered, software-controlled multi-modality device… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 6 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 14 ancestors have a recall of any class.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Cryo And Thermo Therapy System ( Model:VU-COTO02) : The device provides a combination of cold, heat, contrast, and compression therapies. It is intended to treat post-surgical and trauma 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. The…
Read the full statement (190 words)
Cryo And Thermo Therapy System ( Model:VU-COTO02) :
The device provides a combination of cold, heat, contrast, and compression therapies.
It is intended to treat post-surgical and trauma 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.
The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings and home settings.
Cryo And Thermo Therapy System (Model: VU-COT01-V1, VU-COT01-V2, VU-COTO03) :
The device provides a combination of cold, heat, contrast, and compression therapies.
It is intended to treat post-surgical and trauma 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.
The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253919: Cryo And Thermo Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253919
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026