510(k) Report

FDA applicant

Promatek

Canada H4p 2c9, CA1 decision1986–19860 recalls

FDA records 1 decision for Promatek (Canada H4p 2c9, CA) in 1986: 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 Promatek’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Promatek since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Promatek”

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