BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PainShield MD PLUS

    K Number: K221210 · Decision Nov 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    PainShield MD PLUS
    K Number
    K221210
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanovibronix, Inc.
    Date Received
    April 27, 2022
    Decision Date
    November 23, 2022
    Product Code
    PFW
    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
    PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

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