BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR

    K Number: K011701 · Decision Jun 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    5
    Review Days
    21

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    Basic Information

    Device Name
    BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
    K Number
    K011701
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Taiwan Armada Enterprise Co., Ltd.
    Date Received
    June 1, 2001
    Decision Date
    June 22, 2001
    Product Code
    IOR
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IOR Wheelchair, Mechanical

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    Other Clearances by Taiwan Armada Enterprise Co., Ltd.

    K Number Device Name
    K020472 BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
    K020188 BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
    K020284 BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
    K014198 BIOTECH B990K VIVI WHEELCHAIR