FDA applicant
Thd Spa
FDA records 13 decisions for Thd Spa (Imoa, IT) from 2008 to 2021: 13 510(k) clearances. Most are in product codes FER (Anoscope And Accessories) and JAF (Monitor, Ultrasonic, Nonfetal). Its devices cite 20 predicates, 11 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 Thd Spa’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2008high 2 (2008) · low 0 (2014)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Thd Spa’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