{"publicDeviceRecordKey":"4cc491e6-b964-4207-ab1e-fdc8e88a0c92","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-05-22T00:00:00.000Z","devicePublishDate":"2019-06-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B618N1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"COMPLETE CONTROL System Gen2","versionModelNumber":"1","catalogNumber":null,"dunsNumber":"078505297","companyName":"COAPT LLC","deviceCount":1,"deviceDescription":"The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. ","DMExempt":false,"premarketExempt":false,"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":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K191083","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41497","gmdnPTName":"Myoelectric hand prosthesis","gmdnPTDefinition":"A powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device features an integral or proximally mounted motor (e.g., electric, hydraulic) which actuates hand/finger movements (e.g., gripping, pinching, pointing). The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GXY","productCodeName":"Electrode, Cutaneous"}]},"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}