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

    NEXT WAVE PHYSIOACOUSTIC MATTRESS

    K Number: K934886 · Decision Jun 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    240

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    Basic Information

    Device Name
    NEXT WAVE PHYSIOACOUSTIC MATTRESS
    K Number
    K934886
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5975
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Next Wave, Inc.
    Date Received
    October 12, 1993
    Decision Date
    June 9, 1994
    Product Code
    IRO
    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
    IRO Vibrator, Therapeutic

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