FDA applicant

Sunbeam Health Division

Bridgeview, IL2 decisions1996–19960 recalls

FDA records 2 decisions for Sunbeam Health Division (Bridgeview, IL) in 1996: 2 510(k) clearances. All are in product code IRT (Pad, Heating, Powered). Its devices cite 4 predicates, 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 Sunbeam Health Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunbeam Health Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sunbeam Health Division’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Sunbeam”

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

Sunbeam Corp. 3 Sunbeam-Oster Household Products 1 Sunbeam Appliance Service Co. 1

Sunbeam Health Division

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sunbeam”