BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇭 Switzerland

    DolorClast Radial

    K Number: K220538 · Decision Jul 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    759
    Registration Numbers
    759
    Same Product Code
    99
    Applicant Total
    28
    Review Days
    136

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    Basic Information

    Device Name
    DolorClast Radial
    K Number
    K220538
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.M.S Electro Medical Systems S.A
    Date Received
    February 25, 2022
    Decision Date
    July 11, 2022
    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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