{"publicDeviceRecordKey":"2a7de597-3b8c-4386-939e-7c9886b2739e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-05-11T00:00:00.000Z","devicePublishDate":"2019-02-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04560340090957","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"HAL for Medical Use","versionModelNumber":"HAL-ML05-DMMUS","catalogNumber":null,"dunsNumber":"714480766","companyName":"CYBERDYNE, INC.","deviceCount":1,"deviceDescription":"Number of legs: Double\nLeg length: Medium\nHip width: Medium","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":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63288","gmdnPTName":"Neuro-controlled ambulation exoskeleton","gmdnPTDefinition":"A battery-powered, bionic, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function, via cutaneous electrodes, to the device motor assembly. It is intended to improve gait after use and may also be used in a pre-programmed configuration. The system includes an exoskeleton structure made of metal with electric motors and mechanical actuators; it is typically strapped to the legs over clothing. It is intended for multiple-patient use in a controlled clinical setting (e.g., gait lab, rehabilitation centre).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HCC","productCodeName":"Device, Biofeedback"},{"productCode":"PHL","productCodeName":"Powered Exoskeleton"}]},"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":[]}}