FDA applicant
Amylior, Inc.
FDA records 3 decisions for Amylior, Inc. (Note-Dame Of Ile Perrot,Quebec, CA) from 2000 to 2009: 3 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Its devices cite 2 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
How often FDA has decided Amylior, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2007high 1 (2009) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Amylior, 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