510(k) Report

510(k) · Cleared

Cleared

Intermittent Pneumatic Compression Device

K141390510(k) TraditionalCleared Nov 18, 2014175-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wuhan Landing Medical Hi-Tech, Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Nov 18, 2014 as substantially equivalent to K123830 (Dalian Labtek Science & Development Co., Ltd., 2013) after a 175-day review. Its family tree reaches back 4 generations to 1996.

Decided
Nov 18, 2014
Review
175 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K953648 (1996). 5 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 4 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
  2. 3 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
  3. 2 generations backK112677 The Venous Assist SystemDaesung Maref Co., Ltd. · 2012
  4. 1 generation backK123830 Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd. · 2013
  5. This deviceK141390 Intermittent Pneumatic Compression DeviceWuhan Landing Medical Hi-Tech, Ltd. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K953648A-V Impulse System Model 6060Novamedix, Ltd.1996—
−3K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall2004—
−2K112677The Venous Assist SystemDaesung Maref Co., Ltd.2012—
−1K123830Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd.2013—
0 (this device)K141390Intermittent Pneumatic Compression DeviceWuhan Landing Medical Hi-Tech, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K141390, 1996–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JOW? 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 JOW device

  1. #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K123830Intermittent Pneumatic Compression Device
Summary page 5
…ittent pneumatic compression device Model: LD Q-IPC III Classification Panel: Cardiovascular Product Code: JOW Device Classification: Class II 4. The Predicate Devices K123830 Veinoflow SCD, LBTK-M-I 5001 5. Device Description The LD Q-IPC III Intermittent pneumatic compression device is a pneumatic…
Dalian Labtek Science & Development Co., Ltd.2013—

Also cleared against K123830: 1 other device →

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 18 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
  • None of the 5 ancestors has a recall.
  • 1 other device also cites its predicate K123830.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · JOW

7in 2025

2007: 62008: 42009: 32010: 182011: 112012: 132013: 172014: 162015: 102016: 92017: 92018: 112019: 112020: 142021: 162022: 72023: 62024: 82025: 72026 (partial year): 6
2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007: 66 days median2008: 112 days median2009: 84 days median2010: 71 days median2011: 104 days median2012: 63 days median2013: 94 days median2014: 91 days median2015: 160 days median2016: 121 days median2017: 116 days median2018: 136 days median2019: 88 days median2020: 158 days median2021: 132 days median2022: 80 days median2023: 160 days median2024: 197 days median2025: 168 days median2026 (partial year): 252 days median
2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2008: 72010: 22011: 32012: 22017: 12019: 1
2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007: 122008: 362009: 452010: 662011: 502012: 1002013: 1692014: 932015: 1372016: 1502017: 1492018: 1142019: 1022020: 502021: 342022: 272023: 572024: 302025: 24
2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007666012
20084112736
2009384045
20101871266
201111104350
201213632100
201317940169
20141691093
2015101600137
201691210150
201791161149
2018111360114
201911881102
202014158050
202116132034
2022780027
20236160057
20248197030
20257168024
202662520—

What is it indicated for?

The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients.

Leg Compression

The use of the product with Calf Cuff and Thigh Cuff is indicated for:

1. Deep vein thrombosis and pulmonary embolism prophylaxis.

Foot Compression

The use of the product with Foot Cuff is indicated for:

1. Circulation enhancement.

2. Deep vein thrombosis prophylaxis.

3. Edema-Acute.

4. Edema-Chronic.

5. Extremity pain incident to trauma or surgery.

6. Leg Ulcers.

7. Venous stasis /Venous insufficiency.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K141390: Intermittent Pneumatic Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141390

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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