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

    SONACARE SOUND MASSAGER

    K Number: K921000 · Decision Mar 31, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    783
    Registration Numbers
    783
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    398

    Basic Information

    Device Name
    SONACARE SOUND MASSAGER
    K Number
    K921000
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    HONOR TRADING, LTD.
    Date Received
    February 27, 1992
    Decision Date
    March 31, 1993
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

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