FDA applicant

Imc-Heart Way LLC

Fort Myers, FL10 decisions2003–20070 recalls

FDA records 10 decisions for Imc-Heart Way LLC (Fort Myers, FL) from 2003 to 2007: 10 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). 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 Imc-Heart Way LLC’s devices, and how often a recall has named them.

FDA decisions per year

5in 2007

2007high 5 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Imc-Heart Way LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Imc-Heart Way LLC

Which product codes does it file in?

What has FDA decided for it lately?