510(k) Report

FDA applicant

Sauna Magic, Inc.

Mississauga, Ontario, CA1 decision1992–19920 recalls

FDA records 1 decision for Sauna Magic, Inc. (Mississauga, Ontario, CA) in 1992: 1 510(k) clearance. All are in product code IMB (Cabinet, Moist Steam). 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 Sauna Magic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sauna Magic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sauna Magic, 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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