WINDMERE PRELUDE III— 510(k) K924237

Substantially Equivalent

Windmere Corp.

FDA 510(k) clearance K924237 for WINDMERE PRELUDE III, Substantially Equivalent on 1993-10-18. Applicant: Windmere Corp..

Clearance details

Applicant: Windmere Corp.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1992-08-24
Decision date: 1993-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

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Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.