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510(k) Data Aggregation

    K Number
    K063328
    Device Name
    IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-04-27

    (175 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Model-Allure (HP6), powered wheelchair is to provide mobility to adults, weighing up to 350 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
    Device Description
    Not Found
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    K Number
    K063307
    Device Name
    ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-02-27

    (118 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.
    Device Description
    Not Found
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    K Number
    K063320
    Device Name
    ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-02-27

    (117 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.
    Device Description
    Not Found
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    K Number
    K063203
    Device Name
    ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-02-13

    (113 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
    Device Description
    Not Found
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    K Number
    K063475
    Device Name
    IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-01-23

    (68 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Model-Tiara (P4AS) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
    Device Description
    Not Found
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    K Number
    K063474
    Device Name
    ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2006-12-22

    (36 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.
    Device Description
    Not Found
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    K Number
    K052008
    Device Name
    IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2005-09-16

    (53 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the HP-7 provide mobility to adults limited to thing position that have the to operates a simple han Capa
    Device Description
    Model HP-7 Power Wheelchair
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    K Number
    K031897
    Device Name
    PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2003-09-23

    (96 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the PF-2 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
    Device Description
    Model PF-2, Four Wheel Electric Scooter
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    K Number
    K030432
    Device Name
    IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2003-05-01

    (80 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the IMC- Heartway Model HPS Wheelchair is to provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.
    Device Description
    Not Found
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    K Number
    K030427
    Device Name
    HP-3 HD ELECTRIC WHEELCHAIR
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2003-04-18

    (67 days)

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

    IMC-HEARTWAY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.
    Device Description
    Model HP-3 HD Electric Wheelchair
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