{"publicDeviceRecordKey":"dc239adf-c5c3-453e-9be1-6afbc1f332b5","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-10-08T00:00:00.000Z","devicePublishDate":"2021-09-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09120077180076","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"LEXO","versionModelNumber":"R1","catalogNumber":null,"dunsNumber":"301726803","companyName":"tyromotion GmbH","deviceCount":1,"deviceDescription":"The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47516","gmdnPTName":"Treadmill/elliptical gait rehabilitation system","gmdnPTDefinition":"An assembly of electrically-powered devices designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. It primarily consists of a speed-regulated treadmill or elliptical to facilitate gait; an overhead patient support assembly with pulleys, harness, and straps to unload patient weight; a robotic orthosis system attached to the patient's legs individually, or in the form of pedals, to guide leg movements; side-mounted rails for patient support; an operator control unit to regulate speed/elevation and display related data; and sometimes patient incentive features.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IKK","productCodeName":"System, Isokinetic Testing And Evaluation"}]},"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":[]}}