510(k) Report

FDA applicant

Won Industrial Co.

Buena Park, CA2 decisions2011–20122 recalls

FDA records 2 decisions for Won Industrial Co. (Buena Park, CA) from 2011 to 2012: 2 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are 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 Won Industrial Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2017

2017: 2
2011high 2 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Won Industrial Co. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Won Industrial Co.’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 Tube2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K102319Compressible Limb and Circulation Therapy System Model Wic-2008Won Industrial Co. · 20112cite it

What has FDA decided for it lately?

  • K120166Compressible Limb and Circulation Therapy SystemWon Industrial Co. · 20122 recalls
  • K102319Compressible Limb and Circulation Therapy System Model Wic-2008Won Industrial Co. · 2011

All 2 as Won Industrial Co. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K120166Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for…Jan 13, 2017Class II
  • K120166Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection…Jan 13, 2017Class II