<?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>c0056d8d-81aa-45c8-9784-29ff305d6cbf</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2022-06-10</publicVersionDate><devicePublishDate>2021-07-09</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>50749756562008</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00749756562003</containsDINumber><pkgQuantity>12</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>00749756562003</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>DeRoyal</brandName><versionModelNumber>9262-00</versionModelNumber><catalogNumber>9262-00</catalogNumber><dunsNumber>096372255</dunsNumber><companyName>DEROYAL INDUSTRIES, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>ARM PROTECTORS</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(888)938-7828</phone><phoneExtension xsi:nil="true"/><email>udisupport@deroyal.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44284</gmdnCode><gmdnPTName>Arm friction/impact protector</gmdnPTName><gmdnPTDefinition>A device designed to be worn over some length of the arm (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb and its skin from friction and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the arm, or has a tubular sleeve design; it is not dedicated to the elbow. It is typically used by persons who have thinning skin or skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FMP</productCode><productCodeName>Protector, skin pressure</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>