FDA applicant

Electromed Intl., Ltd.

Waltham, MA23 decisions1981–20010 recalls

FDA records 23 decisions for Electromed Intl., Ltd. (Waltham, MA) from 1981 to 2001: 23 510(k) clearances. Most are in product codes IZO (Generator, High-Voltage, X-Ray, Diagnostic) and DRX (Electrode, Electrocardiograph). Its devices cite 6 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, radiology panel, where it files most

How often FDA has decided Electromed Intl., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electromed Intl., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Electromed Intl., 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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Other applicant names beginning “Electromed”

FDA records each applicant name separately; these may or may not be the same firm.

Electromed, Inc. 6 Electromed Imaging, Inc. 1

Electromed Intl., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Electromed”