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510(k) Data Aggregation

    K Number
    K250266
    Device Name
    Ceragem Automatic Thermal Massager (CGM MB-2401)
    Manufacturer
    CERAGEM Co, Ltd.
    Date Cleared
    2025-07-11

    (162 days)

    Product Code
    JFB, IRO, IRP, ISA
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAGEM Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243644
    Device Name
    Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
    Manufacturer
    CERAGEM Co, Ltd.
    Date Cleared
    2025-01-08

    (43 days)

    Product Code
    JFB, IRP
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAGEM Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: - Temporary relief of minor muscle and joint pain stiffness - Temporary relief of minor joint pain associated with arthritis - Temporary increase in local circulation where applied - Relaxation of muscles The Air Cell Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Not Found
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    K Number
    K243355
    Device Name
    Ceragem Automatic Thermal Massager (CGM-MB-1902)
    Manufacturer
    CERAGEM Co, Ltd.
    Date Cleared
    2024-11-27

    (29 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAGEM Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1902 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: - Temporary relief of minor muscle and joint pain stiffness - Temporary relief of minor joint pain associated with arthritis - Temporary increase in local circulation where applied - Relaxation of muscles
    Device Description
    Not Found
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    K Number
    K220572
    Device Name
    Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
    Manufacturer
    CERAGEM Co, Ltd.
    Date Cleared
    2022-06-17

    (109 days)

    Product Code
    JFB, IRP
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAGEM Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: -Temporary relief of minor muscle and joint pain stiffness -Temporary relief of minor joint pain associated with arthritis -Temporary increase in local circulation where applied - Relaxation of muscles The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.
    Device Description
    The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature. This feature utilizes an "air compression transfer," and its principle is as follows: Air Cell Massager consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 4 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure cognized to the sensor, cycling airflow into and out of sleeves to compress body.
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    K Number
    K202937
    Device Name
    Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
    Manufacturer
    Ceragem Co, Ltd.
    Date Cleared
    2021-03-18

    (169 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ceragem Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: - Temporary relief of minor muscle and joint pain stiffness - Temporary relief of minor joint pain associated with arthritis - Temporary increase in local circulation where applied - Relaxation of muscles
    Device Description
    The Ceragem Automatic Thermal Massager which offers two models, CGM MB-1701 & CGM MB-1702 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from up and down movement of the internal motor, and heat from the internal and external projectors. The main components of the subject device are a main table mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main table has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and up/down and vertically along the spinal line. The main table mat has a heating pad for thermal effect. The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect. The only difference between the model CGM MB-1701 and the CGM MB-1702 is that the CGM MB-1701 has an air massage module for calf on the supporting mat. The supporting mat of the both models has a heating pad.
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    K Number
    K202113
    Device Name
    Ceragem Automatic Thermal Massager, Model CGM-MB-1901
    Manufacturer
    Ceragem Co, Ltd.
    Date Cleared
    2021-03-02

    (215 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ceragem Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: - Temporary relief of minor muscle and joint pain stiffness - Temporary relief of minor joint pain associated with arthritis - Temporary increase in local circulation where applied - Relaxation of muscles
    Device Description
    The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors. The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only. The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
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