FDA applicant

Fusmobile, Inc.

Alpharetta, GA1 decision2025–20250 recalls

FDA records 1 decision for Fusmobile, Inc. (Alpharetta, GA) in 2025: 1 De Novo grant. All are in product code SGN (High Intensity Focused Ultrasound System For…). 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 Fusmobile, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

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

Planning a device like Fusmobile, Inc.’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

Fusmobile, Inc.

Which product codes does it file in?

What has FDA decided for it lately?