510(k) Report

FDA applicant

Lsvt Global, LLC

Tucson, AZ1 decision2009–20090 recalls

FDA records 1 decision for Lsvt Global, LLC (Tucson, AZ) in 2009: 1 510(k) clearance. All are in product code LEZ (Aids, Speech Training For The Hearing Impaired…). 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, last Nov 3, 2026

How often FDA has decided Lsvt Global, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Lsvt Global, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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