LogoFDA 510(k) Search
Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K151492
    Device Name
    Kudu
    Manufacturer
    R82 A/S
    Date Cleared
    2016-05-20

    (352 days)

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

    R82 A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kudu is a wheelchair intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces.
    Device Description
    Not Found
    Ask a Question
    K Number
    K100084
    Device Name
    MULTI FRAME WHEELCHAIR
    Manufacturer
    R82 A/S
    Date Cleared
    2010-04-12

    (90 days)

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

    R82 A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi Frame's intended function and use is provide mobility to children limited to a sitting position.
    Device Description
    The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning.
    Ask a Question
    K Number
    K061810
    Device Name
    COUGAR WHEELCHAIR
    Manufacturer
    R82 A/S
    Date Cleared
    2006-08-07

    (41 days)

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

    R82 A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cougar Wheelchair's intended function and use is to provide mobility to persons limited to a sitting position.
    Device Description
    The wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front pivoting casters for steering and turning.
    Ask a Question
    K Number
    K033460
    Device Name
    CHEETAH WHEELCHAIR
    Manufacturer
    R82 A/S
    Date Cleared
    2004-03-26

    (148 days)

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

    R82 A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheetah Wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.
    Device Description
    Not Found
    Ask a Question
    K Number
    K030882
    Device Name
    RABBIT MOBILE STANDING FRAME
    Manufacturer
    R82 A/S
    Date Cleared
    2003-04-04

    (15 days)

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

    R82 A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to The itabolt Moone Banding, Frances anding, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is storiall daring meremental whigh cood head, neck, and upper body control, and is atmized by a chird the dasping of their own volition, but requires support and alignment in weight bearing.
    Device Description
    Rabbit Mobile Standing Frame
    Ask a Question

    Page 1 of 1