<?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>46512007-4197-4d59-8592-2a9527749e3a</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-03-26</publicVersionDate><devicePublishDate>2025-03-18</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>09420051789999</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Spex Limited</brandName><versionModelNumber>1267-3852-800</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>748649195</dunsNumber><companyName>SPEX LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>Spex Lateral Medium Easy-Release Strap for Comfi Cover</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</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>+64330079790</phone><phoneExtension xsi:nil="true"/><email>solutions@spexseating.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>45887</gmdnCode><gmdnPTName>Wheelchair head/trunk support, prefabricated</gmdnPTName><gmdnPTDefinition>A prefabricated (non-customized) padded and contoured device designed to attach to the back/seat of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort. It may include armrests, a cushioned seat, a belt/harness, thigh support, and/or a tray table. It might additionally be designed for use as a car seat to provide support in vehicles during transportation. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IMS</productCode><productCodeName>Support, Head And Trunk, Wheelchair</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>