<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>5b112ac9-8798-41c5-b396-2636bce0c148</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-12-12</publicVersionDate><devicePublishDate>2023-12-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M36882001</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>LUMEX</brandName><versionModelNumber>8200</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>132016168</dunsNumber><companyName>GF HEALTH PRODUCTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>LUMBAR CUSHION ROLL-GEL/VISCO</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>7703684700</phone><phoneExtension xsi:nil="true"/><email>cs@grahamfield.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>41057</gmdnCode><gmdnPTName>Lumbar cushion</gmdnPTName><gmdnPTDefinition>A soft pillow or pad used to provide support and comfort to the user&apos;s lower back, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to support the natural curvature of the lower spine, improve posture, relax muscles, and relieve painful pressure points. The device is typically placed between the lower back and the back of a seat/chair while the user is seated.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KIC</productCode><productCodeName>Cushion, Flotation</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>