{"publicDeviceRecordKey":"dbc878e0-f46c-4fad-8adc-b818e6b08887","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-09-06T00:00:00.000Z","devicePublishDate":"2021-08-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00850008449727","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Ergostyle FX","versionModelNumber":"ES5821","catalogNumber":null,"dunsNumber":"826316098","companyName":"PIVOTAL HEALTH SOLUTIONS, INC.","deviceCount":1,"deviceDescription":null,"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":"46083","gmdnPTName":"Traction table, line-powered","gmdnPTDefinition":"A mobile, mains electricity (AC-powered) table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient?s spine, or apply a rotational roller mechanism protruding through the table surface to the spine, or employ masts and traction accessories for lumbar and cervical traction in a sitting position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is used in a healthcare facility.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"INQ","productCodeName":"Table, Powered"}]},"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":[]}}