510(k) Report

FDA applicant

Myocene

Liège, BE1 decision2025–20250 recalls

FDA records 1 decision for Myocene (Liège, BE) in 2025: 1 De Novo grant. All are in product code SDX (Neuromuscular Stimulator And Exercise…). 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, neurology panel, where it files most

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

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Myocene by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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