510(k) Report

FDA applicant

Therasys, Inc.

Moraine, OH1 decision1999–19990 recalls

FDA records 1 decision for Therasys, Inc. (Moraine, OH) in 1999: 1 510(k) clearance. All are in product code ITH (Equipment, Traction, Powered). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Therasys, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Therasys, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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