Card Guard Model CG-7100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964836 ↗

FDA Product Code

DXH

FDA applicant

Card Guard Scientific Survival , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Card Guard Personal Electrocardiogram Transmitter, Model Cg-6206/6306

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• Cg-6108 Act-Il Continuous ECG Monitor and Arrythmia Detector

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See all devices from Card Guard Scientific Survival, Ltd. →

• What is the primary purpose of the Card Guard Model CG-7100 in clinical settings?

  The Card Guard Model CG-7100 is designed to record non-standard 12-lead ECG data internally and transmit cardiac recordings remotely. It is specifically intended for evaluating transient cardiac symptoms by allowing patients to activate the device when symptoms occur. The recorded data can then be transferred telephonically to a receiving unit in a physician’s office, hospital, or healthcare facility for diagnostic review.

• Is the Card Guard Model CG-7100 reusable or intended for single-use, and what does that mean for sterility?

  The Card Guard Model CG-7100 is explicitly labeled as a single-use device. Upon activation, it is intended for sterile use, though the regulatory documentation does not specify the sterilization method. This means each unit is meant to be used once by a single patient before disposal, ensuring patient safety and sterility standards are maintained.

• How does one retrieve the ECG data recorded by the Card Guard Model CG-7100?

  The device records ECG data internally and facilitates telephonic transfer of that data to a receiving unit located in a healthcare setting. No additional accessories are required beyond a compatible receiving system for data retrieval, making the process straightforward for diagnostic review.

• What regulatory pathway was followed for the FDA clearance of the Card Guard Model CG-7100?

  The Card Guard Model CG-7100 underwent a traditional 510(k) review process and was cleared by the FDA under the classification of Class II medical devices. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the device was determined to be substantially equivalent to a predicate device. The clearance number assigned is K964836.

• Does the Card Guard Model CG-7100 have any special considerations for use in environments with MRI machines?

  The regulatory documentation for the Card Guard Model CG-7100 does not mention MRI safety or compatibility. Therefore, it is not recommended for use in or near MRI environments unless specific safety assessments or clearances have been provided by the manufacturer outside of the documented regulatory submission.