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510(k) Data Aggregation

    K Number
    K072311
    Device Name
    TILITE AERO X
    Manufacturer
    Date Cleared
    2007-09-21

    (35 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.
    Device Description
    The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.
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    K Number
    K024055
    Device Name
    TILITE EVO
    Manufacturer
    Date Cleared
    2002-12-20

    (11 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device (manual, rigid wheelchair) is the same as the predicate device, the TiSport Cross-Sport (manual, rigid wheelchair) manufactured by TiSport, LLC. The intended use for the manual, rigid wheelchair is to provide mobility to physically persons. The manual wheelchair is intended for ongoing daily use. This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions: - Amputee; - Arthritis; - Arthrogriposis; - Cerebral Palsy; - Geriatric conditions; - Head injury or trauma; - Hemiplegic; - Multiple Sclerosis; - Muscular Dystrophy; - Paraplegic; - Polio; - Quadraplegic; - Spina Bifida; - Stoke/CVA; - Tetraplegic; and - Other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
    Device Description
    The TiLite Evo wheelchair is a rigid manual titanium wheelchair.
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    K Number
    K023606
    Device Name
    TILITE YG AND TILITE YGS
    Manufacturer
    Date Cleared
    2002-11-19

    (22 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie® (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows. This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions: - Amputee; - Arthritis: - Arthrogriposis; - Cerebral Palsy; - geriatric conditions; - head injury or trauma; - hemiplegic; - Multiple Sclerosis; - Muscular Dystrophy; - paraplegic; - Polio: - quadraplegic; - Spina Bifida; - Stoke/CVA; - tetraplegic; and - other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
    Device Description
    The TiLite YG and YGS model wheelchairs are rigid manual titanium wheelchairs.
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    K Number
    K020539
    Device Name
    TIPOWER POWERDRIVE AND RIMPOWER X & SX
    Manufacturer
    Date Cleared
    2002-06-20

    (121 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
    Device Description
    The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.
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    K Number
    K020639
    Device Name
    TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
    Manufacturer
    Date Cleared
    2002-06-20

    (113 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
    Device Description
    The TiPower TR Rim Power and TiPower TRA RimPower are rigid power/manual titanium wheelchairs.
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    K Number
    K990555
    Device Name
    TISPORT X AND TISPORT XC
    Manufacturer
    Date Cleared
    1999-03-22

    (28 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Scierosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
    Device Description
    The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.
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    K Number
    K990358
    Device Name
    CROSS SPORT, RIGID WHEELCHAIR
    Manufacturer
    Date Cleared
    1999-02-26

    (21 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISPORT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Post polio Spina Bifada Amputee
    Device Description
    The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.
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