Patient data recorder, long-term, electrocardiograph

Intended purpose

The myPatch®sl ECG Recorder is a small digital Holter recorder intended for use by professionals to acquire ECG data from a patient in a clinical, point of care or at a patient setting. This Holter device is intended to record up to 3 channels of ECG data continuously up to 14 days. Due to the continual wearing of a Holter monitor, this is a medical device that is used both in professional healthcare facilities and outside those facilities. This description meets the definition of a home use device.