{"publicDeviceRecordKey":"d5127bca-bdfc-4fbb-8c9b-ec0943c19799","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-03-27T00:00:00.000Z","devicePublishDate":"2016-09-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00861803000327","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ReWalk(TM) Rehabilitaiton","versionModelNumber":"50-30-0001","catalogNumber":null,"dunsNumber":"533320867","companyName":"LIFEWARD LTD","deviceCount":1,"deviceDescription":"Powered Exoskeleton - rehabilitation institution use","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":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (508) 251-1154","phoneExtension":null,"email":"contact@rewalk.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"DEN130034","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58943","gmdnPTName":"Programmable ambulation exoskeleton, clinical","gmdnPTDefinition":"A battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; 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) under healthcare professional supervision.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"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}