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510(k) Data Aggregation

    K Number
    K233210
    Device Name
    sam CS Long Duration Ultrasound Device
    Manufacturer
    ZetrOZ Systems, LLC
    Date Cleared
    2023-10-25

    (27 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZetrOZ Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
    Device Description
    The sam CS Long Duration Ultrasound Device consists of: - Rechargeable Power Controller and Timer - Ultrasound Generating Applicators Single use disposable accessories - Ultrasonic Coupling Patch The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches. The sam CS Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
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    K Number
    K223019
    Device Name
    sam 2.0 Long Ultrasound Device
    Manufacturer
    ZetrOZ Systems, LLC
    Date Cleared
    2023-06-23

    (267 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZetrOZ Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).
    Device Description
    The sam 2.0 Long Duration Ultrasound Device consists of ultrasound: Power Controller, Cables, Applicators, Coupling Patches. The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware. The Power Controller and cables can be used to power one or two Applicators simultaneously to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with a onetime use Coupling Patches. The system is intended to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues. The system is intended for prescription home use after proper instruction from a healthcare professional.
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    K Number
    K211513
    Device Name
    sam X1 Long Duration Ultrasound Device
    Manufacturer
    ZetrOZ Systems, LLC
    Date Cleared
    2021-08-18

    (96 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZetrOZ Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sam X I Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation
    Device Description
    The sam X1 Long Duration Ultrasound Device consists of: - Rechargeable Power Controller and Timer - Ultrasound Generating Applicators - Single use disposable accessories - Ultrasonic Coupling Patch The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches. The sam X1 Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware. The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 hours) to generate deep heat within body tissues and treat selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
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    K Number
    K191568
    Device Name
    sam 2.0 Long Duration Ultrasound System
    Manufacturer
    ZetrOZ Systems, LLC
    Date Cleared
    2020-03-06

    (267 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZetrOZ Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
    Device Description
    The sam 2.0 Long Duration Ultrasound Device consists of: - Rechargeable Power Controller and Timer - Ultrasound Generating Applicators - Applicator Adaptor Cables Single use disposable accessories - Ultrasonic Coupling Patch The Power Controller and cables can be used to power one or two Applicators simultaneously to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches. The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware. The system is intended for prescription home use to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues and treat selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
    Ask a Question

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