510(k) Report

FDA applicant

Scandia Manufacturing, Ltd.

Bloomington, MN1 decision2002–20025 recalls

FDA records 1 decision for Scandia Manufacturing, Ltd. (Bloomington, MN) in 2002: 1 510(k) clearance. All are in product code IMB (Cabinet, Moist Steam). 5 recalls are 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 Scandia Manufacturing, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scandia Manufacturing, Ltd. since 2007.

Recalls per year

5in 2007

2007: 5
2007high 5 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Scandia”

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