510(k) Report

FDA applicant

Handiflex Corp.

Davie, FL1 decision1997–19970 recalls

FDA records 1 decision for Handiflex Corp. (Davie, FL) in 1997: 1 510(k) clearance. All are in product code JFB (Table, Physical Therapy, Multi Function). 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 Handiflex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Handiflex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Handiflex 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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Which product codes does it file in?

  • JFBTable, Physical Therapy, Multi Function1decision

What has FDA decided for it lately?

  • K971046HandiflexHandiflex Corp. · 1997

The one decision as Handiflex Corp. →