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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Ceragem Automatic Thermal Massager, Model CGM-MB-1901

    K Number: K202113 · Decision Mar 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    65
    Applicant Total
    7
    Review Days
    215

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    Basic Information

    Device Name
    Ceragem Automatic Thermal Massager, Model CGM-MB-1901
    K Number
    K202113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ceragem Co., Ltd.
    Date Received
    July 30, 2020
    Decision Date
    March 2, 2021
    Product Code
    JFB
    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
    JFB Table, Physical Therapy, Multi Function

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    Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702

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    Other Clearances by Ceragem Co., Ltd.

    K Number Device Name
    K250266 Ceragem Automatic Thermal Massager (CGM MB-2401)
    K243644 Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
    K243355 Ceragem Automatic Thermal Massager (CGM-MB-1902)
    K220572 Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
    K202937 Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
    K040031 CERAGEM-C THERMAL ACUPRESSURE MASSAGER