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510(k) Data Aggregation

    K Number
    K233166
    Device Name
    NET Recovery Corp/NET Device
    Manufacturer
    Net Recovery
    Date Cleared
    2024-05-29

    (245 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NET Device is a transcutaneous alternating current stimulator (ACS) that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
    Device Description
    The NET Device is a non-invasive, battery-powered, portable, prescription device designed to provide bilateral, transcranial, transcutaneous, alternating current stimulation (tACS) to be used in patients experiencing opioid withdrawal under the supervision of trained clinical personnel. The system is comprised of one component (the NET Device), accessories (patient leads, electrodes, USB cable), and software (the clinician application). NET Devices, patient leads, and USB cables are reusable. No reprocessing, sterilization, maintenance, or recalibration is required. Electrodes are for single patient use only. The NET Device is used in professional healthcare facility environments (e.g., rehab centers and hospitals). If benefit is not established within 60 minutes of use, discontinue use and seek other methods of treatment.
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    K Number
    K230796
    Device Name
    Sparrow Ascent
    Manufacturer
    Spark Biomedical, Inc.
    Date Cleared
    2023-06-20

    (90 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
    Device Description
    The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
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    K Number
    K221231
    Device Name
    Drug Relief v1
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2022-06-06

    (38 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
    Device Description
    The Drug Relief v1 is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 120 hours. There are three stimulation electrode and one ground electrode which constitute of a titanium needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. The device is rectangular in shape and designed to fit comfortably on the neck. The biocompatible adhesive ensures that the device maintains contact with the skin during normal use. The adhesive fasteners ensure that the electrode needles and the entire device stay in place in a secure manner. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing interpulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K211971
    Device Name
    Drug Relief v1
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2021-11-05

    (134 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
    Device Description
    The Drug Relief v1 is designed to be used as an aid to reduce opioid withdrawal symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 120 hours. There atimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals and a duty cycle of 2 hours ON/1 minute OFF. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K201873
    Device Name
    Sparrow Therapy System
    Manufacturer
    Spark Biomedical, Inc.
    Date Cleared
    2021-01-02

    (179 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sparrow is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
    Device Description
    The Sparrow Therapy System is a non-invasive, battery-operated, prescription device designed to transcutaneously stimulate nerves on and/or around the auricle to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel. The system includes three components: Earpiece, Patient Controller, and the Clinician Application. Sparrow is used in clinical environments (i.e., rehab centers and hospitals) and at home. Users of the subject device include experiencing opioid withdrawal symptoms.
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    K Number
    K173861
    Device Name
    Drug Relief
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2018-05-02

    (133 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drug Relief is a percutaneous nerve field stimulatory (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX, and X, and the occipital nerves identified by transillumination.
    Device Description
    The Drug Relief™ is designed to aid in the treatment of opiate withdrawal symptoms by the method of electrical stimulation at the auricular stimulation points. The Drug Relief is a wearable, battery-operated device that is designed to administer periodical low-level electrical pulses to the ear over five days / 120 hours (2 hours ON/1 minute OFF) from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of Cranial Nerves on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    DEN170018
    Device Name
    NSS-2 System
    Manufacturer
    Innovative Health Solutions (IHS), Inc.
    Date Cleared
    2017-11-15

    (243 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Product Code :

    PZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
    Device Description
    NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).
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