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510(k) Data Aggregation

    K Number
    K000739
    Device Name
    EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Date Cleared
    2000-10-24

    (231 days)

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

    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000678
    Device Name
    RAEBBITT/EVOLUTION POWERED WHEELCHAIR
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Date Cleared
    2000-09-18

    (202 days)

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

    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000497
    Device Name
    VOYAGER/VIPER WHEELCHAIR
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Date Cleared
    2000-03-08

    (22 days)

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

    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000602
    Device Name
    PROTEGE WHEELCHAIR
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Date Cleared
    2000-03-03

    (9 days)

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

    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991590
    Device Name
    C-LEG (3C100)
    Manufacturer
    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
    Date Cleared
    1999-07-08

    (62 days)

    Product Code
    ISW
    Regulation Number
    890.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fitting of lower limb prosthesis . Highly mobile individuals and/or individuals who need stance stability .
    Device Description
    C-LEG (3C100) is a microprocessor-controlled knee joint system with hydraulic stance and swing phase control. The C-LEG immediately adapts to different walking speeds and provides knee stability. The C-LEG (3C100) is recommended for lower limb amputees weighing up to 110 kg (220 pounds) who have a moderate (level 2 or 3) functional level. It is a monocentric knee joint composed of: - Carbon Fiber Frame ● - Hydraulics with Servo Motor ● - Electronics . - Distal Tube Clamp ● - . Upper Joint - Shin Tube Adapter Components of the C-LEG (3C100) are the following: - Electronic Knee Joint 3C87 ● - 2R90 Tube Adapter or . - Tube Adapter with Torsion Adapter 2R91 . - Rotation Adapter 4R57 . Accessories are the following: • 757L17 Charging Device - Power Unit ● 757L16 - Prosthetic Foot 1D10, 1D25, 1A30 . - Foam Cover ● 3826 - . 4X70 Slider Software - Extension Cable . 4X72 - 4X71 PC Interface . - 4R302 Transportation Case ●
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