FDA applicant
Labac Systems, Inc.
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
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.
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.
See the 510(k) Report