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

    Ceragem Automatic Thermal Massager (CGM MB-2401)

    K Number: K250266 · Decision Jul 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    65
    Applicant Total
    7
    Review Days
    162

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    Basic Information

    Device Name
    Ceragem Automatic Thermal Massager (CGM MB-2401)
    K Number
    K250266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ceragem Co., Ltd.
    Date Received
    January 30, 2025
    Decision Date
    July 11, 2025
    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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    Other Clearances by Ceragem Co., Ltd.

    K Number Device Name
    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
    K202113 Ceragem Automatic Thermal Massager, Model CGM-MB-1901
    K040031 CERAGEM-C THERMAL ACUPRESSURE MASSAGER