<?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>efd1ab88-01bf-4fb7-a8a0-82f879e93493</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-02-10</publicVersionDate><devicePublishDate>2025-01-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08055715709016</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>BIKO</brandName><versionModelNumber>BIKO LARGE BLU 864 DIFF.RUOTA LIBER</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>432070019</dunsNumber><companyName>ORMESA SRL</companyName><deviceCount>1</deviceCount><deviceDescription>Medical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper extremity motor control is required to properly steer the handlebars. Even those who have difficulty controlling their balance during the journey will be able to benefit from the use of the tricycle thanks to the stability offered by the whole system.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</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/><gmdnTerms><gmdn><gmdnCode>31142</gmdnCode><gmdnPTName>Assistive foot-propelled tricycle</gmdnPTName><gmdnPTDefinition>A vehicle with three wheels mounted on a slender frame which the user with a disability sits astride and pedals with their legs to provide a means of transportation, typically without the attendance of another person. It is designed to be operated by the user. The vehicle will enhance the user&apos;s independence in short- to medium-range transportation.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ION</productCode><productCodeName>Exerciser, Non-Measuring</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>