510(k) · Cleared
ClearedCompressible Limb Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wonjin Mulsan Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Feb 27, 2012 as substantially equivalent to K100656 (Wonjin Mulsan Co., Ltd., 2010) after a 115-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it.
- Decided
- Feb 27, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914774 (1992). 5 ancestors in all, the oldest K915638 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914774 Multipulse Sequential Compression UnitTalley Group, Ltd. · 1992
- 3 generations backK013061 Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002
- 2 generations backK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
- 1 generation backK100656 Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
- This deviceK113275 Compressible Limb Therapy SystemWonjin Mulsan Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK161907 Pressure Therapy SystemXiamen Senyang Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK203019 LF900Daesung Maref Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK181409 Pressure Therapy System PT1003Xiamen Senyang Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914774 | Multipulse Sequential Compression Unit | Talley Group, Ltd. | 1992 | — |
| −3 | K013061 | Biotouch Massage Therapy System | Tactile Systems Technology, Inc. | 2002 | — |
| −2 | K080134 | Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000) | Wonjin Mulsan Co., Ltd. | 2009 | — |
| −1 | K100656 | Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus) | Wonjin Mulsan Co., Ltd. | 2010 | — |
| 0 (this device) | K113275 | Compressible Limb Therapy System | Wonjin Mulsan Co., Ltd. | 2012 | — |
| +1 | K161907 | Pressure Therapy System | Xiamen Senyang Co., Ltd. | 2017 | — |
| +1 | K203019 | LF900 | Daesung Maref Co., Ltd. | 2021 | — |
| +2 | K181409 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K100656 | Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Summary page 2…__ ___________________ (predicate device) 5 10(k) number None yet k100656 Classification Class H1 Device! IRP (21 CFR Class UI Device! IRP (21 CFR… | 2010 |
What descends from it? (3)
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 20 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K161907 (Xiamen Senyang Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K100656.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 device is indicated for use by medical professionals and patients at borne, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following traumna and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113275: Compressible Limb 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/K113275
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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