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The V-Patch Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

The V-Patch Cardiac Monitor ("V-Patch CM") is a continuous electrocardiogram (ECG) recording device to record, store, and transfer single channel ECGs and is designed for remote ECG data collection and remote monitoring. The device is in the form of an ECG patch that records ECG signals and transmits directly to a Bluetooth™ enabled device. The V-Patch CM has Bluetooth module for transferring ECG data from V-Patch CM to a Bluetooth enabled computing or mobile devices to be accessible to healthcare professionals. The V-Patch CM includes a battery powered electronic unit that is used with off-the-shelf (OTS) disposable medical grade gel electrodes for long term monitoring. The adhesive electrodes should be replaced by the user every 24 hours or when it no longer adheres to skin. The V-Patch CM is a prescription use device and the recorded ECG data is intended to be used with other patient data. The device does not provide any automated ECG analysis.