Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    DEN220059
    Device Name
    NTX100 Tonic Motor Activation (NTX100 ToMAc) System
    Date Cleared
    2023-04-17

    (208 days)

    Product Code
    Regulation Number
    882.5887
    Why did this record match?
    Applicant Name (Manufacturer) :

    Noctrix Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NTX100 Tonic Motor Activation (ToMAc) System® is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and to improve sleep quality in adults refractory to medications.
    Device Description
    The NTX100 Tonic Motor Activation (ToMAc) System® is a non-surgical, non-implantable prescription device intended for the application of low-amplitude electrical stimulation to the common peroneal nerve at lateral side of the knees to reduce symptoms of moderate-severe Restless Legs Syndrome (RLS). Patients will be instructed to use the NTX100 ToMAc System® as needed for symptom relief for up to 120 minutes per 24-hour period. The primary components of the NTX100 ToMAc System® include: - . Therapy Unit - Charge Dispersing Interface (CDI) . - . Charging accessories - Clinician App (for clinician use only) . - . Clinician Computer (for clinician use only)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1