510(k) Report

FDA applicant

Wonjin Mulsan Co., Ltd.

Incheon, KR5 decisions2009–20210 recalls

FDA records 5 decisions for Wonjin Mulsan Co., Ltd. (Incheon, KR) from 2009 to 2021: 5 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Wonjin Mulsan Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2009: 12010: 12012: 12021: 2
2009high 2 (2021) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Wonjin Mulsan Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wonjin Mulsan Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IRPMassager, Powered Inflatable Tube5decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100656Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 20103cite it
  • K113275Compressible Limb Therapy SystemWonjin Mulsan Co., Ltd. · 20122cite it
  • K211283Compressible Limb and Circulation Therapy System, Model POWER-Q2300Wonjin Mulsan Co., Ltd. · 20211cites it
  • K080134Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)Wonjin Mulsan Co., Ltd. · 20091cites it

What has FDA decided for it lately?

  • K211283Compressible Limb and Circulation Therapy System, Model POWER-Q2300Wonjin Mulsan Co., Ltd. · 2021
  • K200660Compressible Limb and Circulation Therapy SystemWonjin Mulsan Co., Ltd. · 2021
  • K113275Compressible Limb Therapy SystemWonjin Mulsan Co., Ltd. · 2012
  • K100656Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
  • K080134Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)Wonjin Mulsan Co., Ltd. · 2009

All 5 as Wonjin Mulsan Co., Ltd. →