FDA applicant
Health Care Innovations, Inc.
FDA records 5 decisions for Health Care Innovations, Inc. (Elyria, OH) from 1987 to 1988: 5 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and GBS (Catheter, Ventricular, General & Plastic Surgery). 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 Health Care Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Health Care Innovations, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Health Care Innovations, 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