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

    BUZZY

    K Number: K130631 · Decision Aug 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    523

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    Basic Information

    Device Name
    BUZZY
    K Number
    K130631
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5975
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mmj Labs, LLC
    Date Received
    March 8, 2013
    Decision Date
    August 13, 2014
    Product Code
    PHW
    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
    PHW Cold Pack And Vibrating Massager

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PHW), ordered by most recent decision date.

    Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Mmj Labs, LLC

    K Number Device Name
    K202993 Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)