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510(k) Data Aggregation

    K Number
    K102734
    Device Name
    COMFORT STANDING WHEELCHAIR, HERO SERIES
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2010-12-14

    (83 days)

    Product Code
    IPL, COM
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
    Device Description
    The COMFORT Standing Wheelchair is an indoor / outdoor standup wheelchair that is manual wheelchair, not an electric power wheelchair, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.
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    K Number
    K072711
    Device Name
    COMFORT POWERED WHEELCHAIR, LY-EB 206
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2007-10-31

    (36 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The COMFORT POWERED WHEELCHAIR, LY-EB206 is an indoor / outdoor Electric Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K072712
    Device Name
    COMFORT ELECTRIC SCOOTER, LY-EW408
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2007-10-31

    (36 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K063030
    Device Name
    COMFORT SCOOTER MODEL LY-EW406
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2006-12-04

    (62 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The COMFORT SCOOTER, LY-EW406 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question
    K Number
    K063032
    Device Name
    COMFORT SCOOTER, MODEL LY-EW415
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2006-10-16

    (13 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The COMFORT SCOOTER, LY-E'V415 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device c in be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K031621
    Device Name
    HERO 1, MODEL LY-ESB220
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2004-01-22

    (244 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
    Device Description
    Not Found
    Ask a Question
    K Number
    K031618
    Device Name
    COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2003-12-18

    (209 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
    Device Description
    The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
    Ask a Question
    K Number
    K030355
    Device Name
    COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2003-05-20

    (106 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB202
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    K Number
    K030356
    Device Name
    COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2003-05-20

    (106 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    COMFORT Powered Wheelchair, Traveller LY-EB103
    Ask a Question
    K Number
    K023581
    Device Name
    COMFORT AGILE SCOOTER, LY-EW303
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2002-12-02

    (39 days)

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

    COMFORT ORTHOPEDIC CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    Not Found
    Ask a Question

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