{"publicDeviceRecordKey":"3a259165-62dd-41a9-9376-8435894a8ca3","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-06-24T00:00:00.000Z","devicePublishDate":"2019-06-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08056182721082","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Human Tecar ","versionModelNumber":"Cylindrical Indifferent Electrode (Plastic connection)","catalogNumber":"16930","dunsNumber":"338736462","companyName":"UNIBELL SRL","deviceCount":1,"deviceDescription":"Cylindrical Indifferent Electrode (Plastic connection)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K181211","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47575","gmdnPTName":"Medium-wave diathermy treatment system","gmdnPTDefinition":"An assembly of devices designed to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The system is commonly used in outpatient, rehabilitation, traumatology, and sports centre settings to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PBX","productCodeName":"Massager, Vacuum, Radio Frequency Induced Heat"}]},"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}