75aa5916-42d0-4689-9034-8ba00824921dUpdatePublished52026-01-092016-09-24In Commercial DistributionB210AC0090PrimaryHIBCCKardia MobileAC-009078523613Alivecor, Inc.1KardiaMobile is a personal EKG device that is capable of recording a Single-Lead EKG. It has two electrodes on the top surface and is powered by a replaceable battery located on the back of the device. Ultrasonic transmission is used to wirelessly transmit EKG data from the device to your smartphone or tablet.falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue62641Electrocardiograph, home-useA device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.falseActiveDXHTransmitters And Receivers, Electrocardiograph, TelephoneDPSElectrocardiographQDAElectrocardiograph Software For Over-The-Counter Usefalsefalse