510(k) Report

FDA applicant

Durtech System Corp.

His-Chih Taipei, TW2 decisions2006–20060 recalls

FDA records 2 decisions for Durtech System Corp. (His-Chih Taipei, TW) in 2006: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Durtech System Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Durtech System Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Durtech System Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IPFStimulator, Muscle, Powered1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

What has FDA decided for it lately?

  • K053284Magbody DT-600Durtech System Corp. · 2006
  • K053285Magbody DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PMDurtech System Corp. · 2006

All 2 as Durtech System Corp. →