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

    BACK MASSAGER

    K Number: K952043 · Decision Sep 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    123

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    Basic Information

    Device Name
    BACK MASSAGER
    K Number
    K952043
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Eight Corners, Inc.
    Date Received
    May 1, 1995
    Decision Date
    September 1, 1995
    Product Code
    LYG
    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
    LYG Massager, Therapeutic, Manual

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