510(k) Report

FDA applicant

Card Guard, Ltd.

Rehovot, IL1 decision1997–19970 recalls

FDA records 1 decision for Card Guard, Ltd. (Rehovot, IL) in 1997: 1 510(k) clearance. All are in product code DXH (Transmitters And Receivers…). 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 Card Guard, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Card Guard, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Card Guard, Ltd. 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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K963725Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Card Guard, Ltd. · 19975cite it

What has FDA decided for it lately?

  • K963725Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Card Guard, Ltd. · 1997

The one decision as Card Guard, Ltd. →

Other applicant names beginning “Card”

FDA records each applicant name separately; these may or may not be the same firm.

Card Guard Scientific Survival, Ltd. 49