510(k) Report

FDA applicant

Enertron Engineering Co.

Hsin Chu City, TW1 decision2004–20040 recalls

FDA records 1 decision for Enertron Engineering Co. (Hsin Chu City, TW) in 2004: 1 510(k) clearance. All are in product code DRM (Compressor, Cardiac, External). Its devices cite 2 predicates, 0 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, cardiovascular panel, where it files most

How often FDA has decided Enertron Engineering Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Enertron Engineering Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Enertron Engineering Co. 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?

  • DRMCompressor, Cardiac, External1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K024215Enertron CPR JackEnertron Engineering Co. · 2004

The one decision as Enertron Engineering Co. →