{"publicDeviceRecordKey":"8a8d76da-70fc-4411-b6f0-be08defdf55f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-01-28T00:00:00.000Z","devicePublishDate":"2023-03-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D481454","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"G342134370","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MetaFlex","versionModelNumber":"13437","catalogNumber":null,"dunsNumber":"118657416","companyName":"ATS Innovations","deviceCount":2,"deviceDescription":"The MetaFlex Glove combines targeted compression to enhance circulation with innovative resistance bands. This powerful combination may reduce pain while improving hand mobility and strength, promoting the functional use of your hands.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"9317039685","phoneExtension":null,"email":"contact@metaflexglove.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16500","gmdnPTName":"Compression/pressure glove","gmdnPTDefinition":"A device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"34200","gmdnPTName":"Finger/hand exerciser","gmdnPTDefinition":"A non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity, density, magnetism, or other means. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ILH","productCodeName":"Splint, Hand, And Components"}]},"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":[]}}