510(k) · Cleared
ClearedCold/Hot Compression
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jkh Health Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Oct 27, 2023 as substantially equivalent to K193550 (Zenith Technical Innovations, 2020) after a 336-day review. Its family tree reaches back 7 generations to 1988. 2 later devices descend from it.
- Decided
- Oct 27, 2023
- Review
- 336 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881632 (1988). 26 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 6 generations backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- 5 generations backK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- 4 generations backK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- 3 generations backK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- 2 generations backK190854 Therm-XZenith Technical Innovations · 2019
- 1 generation backK193550 Therm-XZenith Technical Innovations · 2020
- This deviceK223541 Cold/Hot CompressionJkh Health Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253150 Cryon-X Cold CompressionJkh Health Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240986 Cold CompressionJkh Health Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −6 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| −5 | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| −4 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| −3 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| −2 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| −1 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| 0 (this device) | K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | 2023 | — |
| +1 | K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025 | — |
| +1 | K240986 | Cold Compression | Jkh Health Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K193550 | Therm-XSummary page 5…JOW Regulation Number: 21 CFR 890.5650, 21 CFR 890.5720, 21 CFR 870.5800 Device Class: II Use: Prescription 3. Predicate device Predicate Device: Therm-X 510(k) Number: K193550 Clearance Date: February 28, 2020 Submitter: Zenith Technical Innovations, LLC Reference Device: NanoTherm and VascuTherm System… | 2020 |
| † | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | 2006 |
What descends from it? (2)
2 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)
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 35 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K253150 (Jkh Health Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K193550.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Cold/Hot Compression combines cold, heat, contrast, and compression therapy. 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) are indicated. Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of…
Read the full statement (116 words)
Cold/Hot Compression combines cold, heat, contrast, and compression therapy. 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) are indicated.
Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Cold/Hot Compression 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223541: Cold/Hot Compression.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223541
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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