FDA applicant
Avanutri Equipamentos DE Saúde
FDA records 1 decision for Avanutri Equipamentos DE Saúde (Tres Rios, BR) in 2026: 1 510(k) clearance. All are in product code IRP (Massager, Powered Inflatable Tube). Its devices cite 1 predicate, 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 Avanutri Equipamentos DE Saúde’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Avanutri Equipamentos DE Saúde’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