510(k) · Cleared
ClearedCold Compression Wrap Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chengdu Cryo-Push Medical Technology Co.,Ltd · IRP Massager, Powered Inflatable Tube
Cleared on Jan 19, 2024 as substantially equivalent to K222669 (Chengdu Cryo-Push Medical Technology Co.,Ltd, 2022) and 1 other predicate after a 326-day review. Its family tree reaches back 10 generations to 1985.
- Decided
- Jan 19, 2024
- Review
- 326 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K850316 (1985). 24 ancestors in all, the oldest K810338 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 6 generations between
- 3 generations backK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- 2 generations backK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- 1 generation backK222669 Cryopush Cold Compression DeviceChengdu Cryo-Push Medical Technology Co.,Ltd · 2022
- This deviceK230524 Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd · 2024
Show all 10 generations
- Root · 10 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 9 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 8 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 7 generations backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- 6 generations backK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- 5 generations backK122154 Powerplay Muscle MassagerFig, LLC · 2012
- 4 generations backK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- 3 generations backK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- 2 generations backK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- 1 generation backK222669 Cryopush Cold Compression DeviceChengdu Cryo-Push Medical Technology Co.,Ltd · 2022
- This deviceK230524 Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −9 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −8 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −7 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −6 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| −5 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| −4 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| −3 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| −2 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| −1 | K222669 | Cryopush Cold Compression Device | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2022 | — |
| 0 (this device) | K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K222669 | Cryopush Cold Compression DeviceSummary page 5…tion No. 21 CFR 890.5650 3. Legally Marketed Predicate Device Trade Name Cryopush Cold Compression Device Classification Ⅱ 510(k) Number K222669 Product Code IRP; IME 1 Chengdu Cryo-Push Medical Te… | 2022 |
| * | K133483 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for Otc UseSummary page 6…o., Ltd Trade Name Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC Use 510(k) Number K133483 Product Code IRP, IME Manufacturer MEDIcept, Inc. 4. Device Description Cold Compression Wrap Pro Device c… | 2014 |
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 39 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- None of the 24 ancestors has a recall.
- 1 other device also cites its predicate K222669.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains.
The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and
simulates kneading and stroking of tissues using an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230524: Cold Compression Wrap Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230524
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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