<?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>7f098d71-bcb5-48ef-ba2e-5d67b01aca52</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-09-25</publicVersionDate><devicePublishDate>2023-09-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00195411206339</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>Hoizon HD</brandName><versionModelNumber>HZ RJEN 27 D7</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>623191137</dunsNumber><companyName>COLLEGE PARK INDUSTRIES, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Horizon HD Foot, Right, Jet Black, Endo IP, 27cm, Category 7</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>1-800-728-7950</phone><phoneExtension xsi:nil="true"/><email>orders@college-park.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>64723</gmdnCode><gmdnPTName>Mechanical-resistance external ankle-foot prosthesis</gmdnPTName><gmdnPTDefinition>A mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ISH</productCode><productCodeName>Component, External, Limb, Ankle/Foot</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>