510(k) Report

FDA applicant

Ws Far IR Medical Technology Co., Ltd.

New Taipei City, TW2 decisions2008–20160 recalls

FDA records 2 decisions for Ws Far IR Medical Technology Co., Ltd. (New Taipei City, TW) from 2008 to 2016: 2 510(k) clearances. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 2 predicates, 1 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 Ws Far IR Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12016: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Ws Far IR Medical Technology Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating2decisions

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080465WS Far Infrared Therapy Unit, Model # TY-101 SeriesWs Far IR Medical Technology Co., Ltd. · 20081cites it

What has FDA decided for it lately?

  • K160849WS (TM) Far-Infrared Therapy Unit, Model KP-B210Ws Far IR Medical Technology Co., Ltd. · 2016
  • K080465WS Far Infrared Therapy Unit, Model # TY-101 SeriesWs Far IR Medical Technology Co., Ltd. · 2008

All 2 as Ws Far IR Medical Technology Co., Ltd. →