<?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>d47ecac9-4cb3-49a7-81f4-8fefce20e55f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-09-01</publicVersionDate><devicePublishDate>2022-12-31</devicePublishDate><deviceCommDistributionEndDate>2024-12-31</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00645517319476</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>Trulife</brandName><versionModelNumber>RSC300-LV-1</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>289728891</dunsNumber><companyName>TRULIFE LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>CASH HING STRN/PUB LG VR BKPD 30</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</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>true</otc><contacts/><gmdnTerms><gmdn><gmdnCode>58757</gmdnCode><gmdnPTName>Spine thermoplastic splint system</gmdnPTName><gmdnPTDefinition>An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IQF</productCode><productCodeName>ORTHOSIS, CERVICAL-THORACIC, RIGID</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>