{"publicDeviceRecordKey":"ee4e3a2e-422a-4b2c-b652-e19fe6e75be3","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-02-10T00:00:00.000Z","devicePublishDate":"2025-01-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08055715701546","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"JUDITTA","versionModelNumber":"JUDITTA-45 B30 DARK GREY, BLACK FRAME","catalogNumber":null,"dunsNumber":"432070019","companyName":"ORMESA SRL","deviceCount":1,"deviceDescription":"Tilting seating system intended for users with significant systemic, neurological, orthopedic impairment; patients with reduced or no degree of mobility, poor control of the trunk and head, Patients who, due to the permanence in a sitting or lying position, have an average risk index of onset of pressure ulcers (according to the Norton or Braden scale), for which the transpiration of the surfaces (back and seat) is decisive for the maintenance of dry skin, to avoid skin maceration and topical infections. Patients with severe structured spinal deformities, in particular major kyphoscoliosis. Patients with difficulty in controlling and tending to lose the proper position of the pelvis, in order to slide forward.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41630","gmdnPTName":"Attendant-only-propelled wheelchair, non-bariatric","gmdnPTDefinition":"A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"INM","productCodeName":"Chair, With Casters"}]},"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":[]}}