510(k) Report

FDA applicant

Labac Systems, Inc.

Highlands Ranch, CO11 decisions1992–19940 recalls

FDA records 11 decisions for Labac Systems, Inc. (Highlands Ranch, CO) from 1992 to 1994: 11 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and KNN (Components, Wheelchair). 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 Labac Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Labac Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Labac Systems, 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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