510(k) Report

FDA applicant

Suretone International

Cape Town, Cape, ZA1 decision2002–20020 recalls

FDA records 1 decision for Suretone International (Cape Town, Cape, ZA) in 2002: 1 510(k) clearance. All are in product code IPF (Stimulator, Muscle, Powered). 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 Suretone International’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Suretone International since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Suretone International’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?

  • IPFStimulator, Muscle, Powered1decision

What has FDA decided for it lately?

  • K011588SuretoneSuretone International · 2002

The one decision as Suretone International →