FDA applicant

Tone-A-Matic International, Inc.

Mississauga, CA4 decisions2013–20230 recalls

FDA records 4 decisions for Tone-A-Matic International, Inc. (Mississauga, CA) from 2013 to 2023: 4 510(k) clearances. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 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, physical medicine panel, where it files most

How often FDA has decided Tone-A-Matic International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Tone-A-Matic International, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tone-A-Matic International, Inc.’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 “Tone-A-Matic”

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

Tone World International 1

Tone-A-Matic International, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Tone-A-Matic”