510(k) · Cleared
ClearedCompressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)
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 Jan 23, 2009 as substantially equivalent to K915638 (Progressive Medical Technology, Inc., 1992) and 1 other predicate after a 371-day review. Its family tree reaches back 2 generations to 1992. 14 later devices descend from it.
- Decided
- Jan 23, 2009
- Review
- 371 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914774 (1992). 3 ancestors in all, the oldest K915638 (1992). 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK914774 Multipulse Sequential Compression UnitTalley Group, Ltd. · 1992
- 1 generation backK013061 Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002
- This deviceK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK100656 Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
- Descendant · 2 generations on · 6 of its ownK102320 Compressible Limb and Circulation Therapy System Model LX7(V7)Daesung Maref Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK113275 Compressible Limb Therapy SystemWonjin Mulsan Co., Ltd. · 2012
- Descendant · 2 generations on · 3 of its ownK102319 Compressible Limb and Circulation Therapy System Model Wic-2008Won Industrial Co. · 2011
- Descendant · 3 generations on · 1 of its ownK161907 Pressure Therapy SystemXiamen Senyang Co., Ltd. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K100656Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010 · cites it directly13descendants
- K102320Compressible Limb and Circulation Therapy System Model LX7(V7)Daesung Maref Co., Ltd. · 2011 · 2 generations on6descendants
- K113275Compressible Limb Therapy SystemWonjin Mulsan Co., Ltd. · 2012 · 2 generations on3descendants
- K102319Compressible Limb and Circulation Therapy System Model Wic-2008Won Industrial Co. · 2011 · 2 generations on3descendants
- K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914774 | Multipulse Sequential Compression Unit | Talley Group, Ltd. | 1992 | — |
| −1 | K013061 | Biotouch Massage Therapy System | Tactile Systems Technology, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K102320 | Compressible Limb and Circulation Therapy System Model LX7(V7) | Daesung Maref Co., Ltd. | 2011 | — |
| +2 | K113275 | Compressible Limb Therapy System | Wonjin Mulsan Co., Ltd. | 2012 | — |
| +2 | K102319 | Compressible Limb and Circulation Therapy System Model Wic-2008 | Won Industrial Co. | 2011 | — |
| +3 | K161907 | Pressure Therapy System | Xiamen Senyang Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K915638 | Talley TM200 Intermttent Compression UnitSummary page 1…re, cycle time and gradient setting Power unit features visual operation status and fault indicators G Substantial Equivalence Information Predicate Device - K915638/KO1 3061 - TALLEY INTERMITTENT UNIT WITH CALF APPLIATOR/ Biotouch Massage Therapy System -… | 1992 |
| * | K013061 | Biotouch Massage Therapy System | 2002 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100656 | Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus) | 2010 | 13 |
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 17 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100656 (Wonjin Mulsan Co., Ltd., 2010) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K915638.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 WHF-314 (POWER Q1000) device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as
Primary lymphedema,
Edema following trauma and sport injuries,
Post immobilization edema,
Venous insufficiencies,
Lymphedema
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080134 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080134: Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080134
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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