510(k) Report

FDA applicant

Intelwave, LLC

Edison, NJ1 decision2006–20060 recalls

FDA records 1 decision for Intelwave, LLC (Edison, NJ) in 2006: 1 510(k) clearance. All are in product code DPS (Electrocardiograph). Its devices cite 4 predicates, 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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Intelwave, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC · 20061cites it

What has FDA decided for it lately?

  • K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC · 2006

The one decision as Intelwave, LLC →