{"publicDeviceRecordKey":"75aa5916-42d0-4689-9034-8ba00824921d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2026-01-09T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B210AC0090","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Kardia Mobile","versionModelNumber":"AC-009","catalogNumber":null,"dunsNumber":"078523613","companyName":"Alivecor, Inc.","deviceCount":1,"deviceDescription":"KardiaMobile 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.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62641","gmdnPTName":"Electrocardiograph, home-use","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DXH","productCodeName":"Transmitters And Receivers, Electrocardiograph, Telephone"},{"productCode":"DPS","productCodeName":"Electrocardiograph"},{"productCode":"QDA","productCodeName":"Electrocardiograph Software For Over-The-Counter Use"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}