BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇺🇸 United States

    BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID

    K Number: K854710 · Decision Apr 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    146

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    Basic Information

    Device Name
    BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID
    K Number
    K854710
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3920
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Reloke Co.
    Date Received
    November 21, 1985
    Decision Date
    April 16, 1986
    Product Code
    KNN
    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
    KNN Components, Wheelchair

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