LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K102304
    Device Name
    BREEZE C MODEL C (3W), BREEZE C (4W)
    Manufacturer
    AFIKIM ELECTRIC VEHICLES
    Date Cleared
    2011-01-07

    (144 days)

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

    AFIKIM ELECTRIC VEHICLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons. The Breeze is also suite for the use of elderly persons and physically disabled persons.
    Device Description
    Breeze C, 3&4 wheels Scooter
    Ask a Question
    K Number
    K051028
    Device Name
    BREEZE
    Manufacturer
    AFIKIM ELECTRIC VEHICLES
    Date Cleared
    2006-01-27

    (280 days)

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

    AFIKIM ELECTRIC VEHICLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suite for the use of elderly persons and physically disabled persons.
    Device Description
    Not Found
    Ask a Question
    K Number
    K041186
    Device Name
    CADDY
    Manufacturer
    AFIKIM ELECTRIC VEHICLES
    Date Cleared
    2004-09-09

    (126 days)

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

    AFIKIM ELECTRIC VEHICLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caddy is a transportable / foldable electric scooter. The Caddy Scooter has been developed especially for those people with Mobility problems are generally problems with walking or with the stamina. wanting or was as a suite for the use of elderly persons and physically disabled persons. The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.
    Device Description
    The Caddy is a transportable / foldable electric scooter.
    Ask a Question

    Page 1 of 1