510(k) · Cleared
ClearedNice1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nice Recovery Systems, LLC · IRP Massager, Powered Inflatable Tube
Cleared on Dec 23, 2014 as substantially equivalent to K071050 (Coolsystems, Inc., 2007) after a 47-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Dec 23, 2014
- Review
- 47 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951769 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK951769 CryopressGrimm Scientific Industries, Inc. · 1995
- 1 generation backK071050 Game Ready Professional Therapy System, Model 550100, Game Ready…Coolsystems, Inc. · 2007 · Recalled
- This deviceK143197 Nice1Nice Recovery Systems, LLC · 2014
- Descendant · cites it directly · 0 of its ownK253150 Cryon-X Cold CompressionJkh Health Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253150Cryon-X Cold CompressionJkh Health Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951769 | Cryopress | Grimm Scientific Industries, Inc. | 1995 | — |
| −1 | K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready… | Coolsystems, Inc. | 2007 | 1 |
| 0 (this device) | K143197 | Nice1 | Nice Recovery Systems, LLC | 2014 | — |
| +1 | K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed…Summary page 5…Game Ready System Manufactured by CoolSystems Inc. K071050 Product Code: ILO/IRP C… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253150 | Cryon-X Cold Compression | 2025 | 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 19 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K253150 (Jkh Health Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071050.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Nice1 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 a healthcare professional in hospital,
outpatient clinics, athletic training settings, or home settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143197: Nice1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143197
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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