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510(k) Data Aggregation

    K Number
    K041187
    Device Name
    A&I SCOOTER, SC-301
    Manufacturer
    WELL SUCCESS BIOTECH INC.
    Date Cleared
    2004-05-25

    (19 days)

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

    WELL SUCCESS BIOTECH INC.

    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 A&I Scooter SC-301 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter 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
    K041190
    Device Name
    A&I POWER WHEELCHAIR, PC-401
    Manufacturer
    WELL SUCCESS BIOTECH INC.
    Date Cleared
    2004-05-25

    (19 days)

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

    WELL SUCCESS BIOTECH INC.

    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 A&I Power Wheelchair, PC-401 is an indoor / outdoor Powered 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.
    Ask a Question
    K Number
    K041193
    Device Name
    A&I SCOOTER, SC-402
    Manufacturer
    WELL SUCCESS BIOTECH INC.
    Date Cleared
    2004-05-25

    (19 days)

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

    WELL SUCCESS BIOTECH INC.

    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 A&I Scooter SC-402 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the stecring column. The device can be disassembled for transport and is provided with an onboard battery charger.
    Ask a Question

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