510(k) Report

FDA applicant

External Counterpulsation Lab

Kfar Saba, IL2 decisions2001–20030 recalls

FDA records 2 decisions for External Counterpulsation Lab (Kfar Saba, IL) from 2001 to 2003: 2 510(k) clearances. All are in product code DRN (Device, Counter-Pulsating, External). 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 External Counterpulsation Lab’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for External Counterpulsation Lab since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — External Counterpulsation Lab 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?

  • DRNDevice, Counter-Pulsating, External2decisions

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.

  • K012141Aecp-a, Automatic External Counterpulsation DeviceExternal Counterpulsation Lab · 20011cites it

What has FDA decided for it lately?

  • K021340Aecp-a, Automatic External Counterpulsation DeviceExternal Counterpulsation Lab · 2003
  • K012141Aecp-a, Automatic External Counterpulsation DeviceExternal Counterpulsation Lab · 2001

All 2 as External Counterpulsation Lab →