510(k) Report

FDA applicant

Ineedmd

Stamford, CT1 decision2004–20040 recalls

FDA records 1 decision for Ineedmd (Stamford, CT) in 2004: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Ineedmd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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