510(k) Report

FDA applicant

Premier Designs

Fresno, CA1 decision1999–19990 recalls

FDA records 1 decision for Premier Designs (Fresno, CA) in 1999: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). 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 Premier Designs’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Premier Designs since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IORWheelchair, Mechanical1decision

What has FDA decided for it lately?

  • K993298E Z ChairPremier Designs · 1999

The one decision as Premier Designs →