510(k) Report

FDA applicant

G. Hirsch and Co., Inc.

Burlingame, CA1 decision1998–19980 recalls

FDA records 1 decision for G. Hirsch and Co., Inc. (Burlingame, CA) in 1998: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 3 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 G. Hirsch and Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for G. Hirsch and Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like G. Hirsch and Co., Inc.’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?

  • IORWheelchair, Mechanical1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982607Manual WheelchairG. Hirsch and Co., Inc. · 19981cites it

What has FDA decided for it lately?

  • K982607Manual WheelchairG. Hirsch and Co., Inc. · 1998

The one decision as G. Hirsch and Co., Inc. →