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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?
    Applicant Name (Manufacturer) :

    Net Recovery

    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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