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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?
    Product Code :

    PFW

    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?
    Product Code :

    PFW

    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
    K221210
    Device Name
    PainShield MD PLUS
    Manufacturer
    NanoVibronix, Inc.
    Date Cleared
    2022-11-23

    (210 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Product Code :

    PFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
    Device Description
    The PainShield MD PLUS is an electrically powered ultrasonic diathermy device intended to relieve pain, muscle spasms, and joint contractures. It is used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a bandage-like patch that adheres to the skin. The PainShield MD PLUS is used to generate continuous wave (CW) ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicators allow treatment of less accessible body parts such as, for example, the heel, the Achilles tendon and the wrist. The device includes the above-mentioned transducers with a cable which connects to a small, rechargeable, battery-powered driver unit and self-adhering patch to apply the transducer on to the skin. The unit is also supplied with a charger used for recharging the battery. Ultrasonic gel is typically not required to be used with the PainShield MD PLUS device. However, for treatment over hairy sites where there might not be adequate sonic coupling between the applicator and the skin, users are instructed to apply standard, FDA-cleared ultrasound gel to the site to improve coupling.
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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?
    Product Code :

    PFW

    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?
    Product Code :

    PFW

    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.
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    K Number
    K130978
    Device Name
    ZTX ULTRASONIC DIATHERMY DEVICE
    Manufacturer
    ZetrOZ INC
    Date Cleared
    2013-11-06

    (211 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Product Code :

    PFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZTX Ultrasonic Diathermy Device is intended 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, and the local increase in circulation. The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
    Device Description
    The ZTX Ultrasonic Diathermy Device consists of a ZTX Ultrasound Power Controller and cable which can be used to power one or two ZTX Ultrasound Applicators simultaneously that each generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per ZTX Ultrasound Applicator. The ZTX Ultrasound Applicators are applied with one time use ZTX Ultrasound Coupling Bandages which hold the ZTX Ultrasound Applicators in place during treatment and allow for the transmission of ultrasound into the body. This provides the operator with the ability to use the device hands-free in a single applicator mode of operation that delivers 0.65W at 3MHz or in a dual applicator mode of operation that provides 1.3W at 3MHz. The ZTX Ultrasound Power Controller displays battery and treatment setting information to the operator and provides control of device treatment time. The ZTX Ultrasound Applicator frequency and power settings are not modifiable by the operator. The ZTX ultrasound applicators and coupling bandage allows for the delivery of ultrasonic energy to tissue at one or two locations simultancously, as determined by a physician. The ZTX Ultrasound Power Controller , ZTX Ultrasound Applicators, interconnecting power cable and ZTX Ultrasound Coupling Bandages comprise the entire ZTX treatment system.
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    K Number
    K081075
    Device Name
    PAINSHIELD MD
    Manufacturer
    NANO VIBRONIX LTD.
    Date Cleared
    2008-08-22

    (128 days)

    Product Code
    PFW
    Regulation Number
    890.5300
    Why did this record match?
    Product Code :

    PFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PainShield"M MD diathermy device is intended to apply ultrasounic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
    Device Description
    The PainShield™ MD is an ultrasonic diathermy device used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a patch that adheres to the skin, as does a bandage.The PainShield™ MD is used to generate continuous wave ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicator allows treatment of less accessible body parts such as, for example, the heel, the achilles tendon and the wrist. The device includes the above-mentioned transducer, a small, rechargeable, battery-powered driver unit and a cable that connects the driver to the transducer.
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    K Number
    K072256
    Device Name
    HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
    Manufacturer
    HILL LABORATORIES CO.
    Date Cleared
    2008-03-12

    (212 days)

    Product Code
    PFW, ILY, LIH
    Regulation Number
    890.5300
    Why did this record match?
    Product Code :

    PFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary). An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: Temporary increases in local blood flow and circulation. Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles. Temporary relief (or relaxation) of muscle spasms. Temporary relief of minor pain and stiffness associated with arthritis
    Device Description
    The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is a device that provides ultrasonic diathermy, interferential current therapy, and infrared lamp therapy. It can be used with one or two ultrasound applicators, and the ultrasound therapy can be applied in a scanned or hands-free manner. An optional infrared light probe is also available.
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