{"publicDeviceRecordKey":"ac3b32bf-79a2-4dfb-b5b4-c691e590fdb9","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-08-18T00:00:00.000Z","devicePublishDate":"2023-08-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G144FM0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Flint Rehab","versionModelNumber":"FM","catalogNumber":null,"dunsNumber":"078285646","companyName":"Flint Rehabilitation Devices LLC","deviceCount":1,"deviceDescription":"FitMi Exercise System","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"30908","gmdnPTName":"Perceptual-coordination assistive training device","gmdnPTDefinition":"A device designed to help train a person with a disability to improve their ability to correctly process and coordinate external stimuli, especially those relating to concepts of space and time, spatial concepts, and eye-hand coordination.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ION","productCodeName":"Exerciser, Non-Measuring"}]},"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":[]}}