FDA applicant

Thermowave Medical Device Corp.

Walker, MI1 decision1983–19830 recalls

FDA records 1 decision for Thermowave Medical Device Corp. (Walker, MI) in 1983: 1 510(k) clearance. All are in product code IRQ (Unit, Heating, 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 Thermowave Medical Device Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermowave Medical Device Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Thermowave Medical Device Corp.

Which product codes does it file in?

What has FDA decided for it lately?