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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?
    Product Code :

    JFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K241193
    Device Name
    AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
    Manufacturer
    Marzzan Lucas Jorge
    Date Cleared
    2025-01-31

    (277 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Product Code :

    JFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
    Device Description
    The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies. The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric. Manual operation systems: - . Headpiece. - . Extension of feet. - Drops. . - Dorso - lumbar release/breakaway - Lateral Flexion. ● Electrical operating systems: - . Horizontal elevation. - . Flexion of the lower limb sector. - Extension or linear movement of the lower limb sector (distraction/traction).
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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?
    Product Code :

    JFB

    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?
    Product Code :

    JFB

    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
    K240168
    Device Name
    N7-S
    Manufacturer
    Nuga Medical Co., Ltd.
    Date Cleared
    2024-09-12

    (234 days)

    Product Code
    JFB, IRP
    Regulation Number
    890.5880
    Why did this record match?
    Product Code :

    JFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. -Temporary relief of minor joint pain associated with arthritis. -The temporary increase in local circulation where applied. -Relaxation of muscle. The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.
    Device Description
    The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage. It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.
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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?
    Product Code :

    JFB

    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?
    Product Code :

    JFB

    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?
    Product Code :

    JFB

    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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    K Number
    K153054
    Device Name
    N5-1
    Manufacturer
    NUGA MEDICAL CO., LTD
    Date Cleared
    2016-02-05

    (108 days)

    Product Code
    JFB, ILY, ISA
    Regulation Number
    890.5880
    Why did this record match?
    Product Code :

    JFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. - Temporary relief of minor joint pain associated with arthritis. - The temporary increase in local circulation where applied. - Relaxation of muscle.
    Device Description
    The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components: - (1) Main assembly - (2) 5-Ball Projector - (3) Remote Control - (4) Accessories Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.
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    K Number
    K140592
    Device Name
    CERAGEM AUTOMATIC THERMAL MASSAGER
    Manufacturer
    Ceragem International Inc.
    Date Cleared
    2014-12-17

    (285 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Product Code :

    JFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager 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
    This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
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