510(k) Report

FDA applicant

Windmere Corp.

Miami Lakes, FL7 decisions1990–19980 recalls

FDA records 7 decisions for Windmere Corp. (Miami Lakes, FL) from 1990 to 1998: 7 510(k) clearances. Most are in product codes IRO (Vibrator, Therapeutic) and ISA (Massager, Therapeutic, Electric). 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 Windmere Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Windmere Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Windmere Corp.’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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