510(k) Report

FDA applicant

Thd Spa

Imoa, IT13 decisions2008–20210 recalls

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, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Thd Spa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 22009: 22010: 12011: 12012: 12013: 12015: 12017: 12018: 12020: 12021: 1
2008high 2 (2008) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Thd Spa by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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