BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NTX150 Tonic Motor Activation (NTX150 TOMAC) System

    Reg #: 3025729280 · FEI: 3025729280 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NOCTRIX HEALTH, INC.
    Registration Number
    3025729280
    FEI Number
    3025729280
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6700 Koll Center Pkwy, Ste 310
    City
    Pleasanton
    State
    CA
    ZIP
    94566
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN220059

    Owner / Operator

    Firm Name
    Noctrix Health, Inc.
    Operator Number
    10087959
    Address
    6700 Koll Center Pkwy, Ste 310
    City
    Pleasanton
    State
    CA
    Postal Code
    94566
    Country
    US
    Correspondent
    Shriram Raghunathan

    Products

    Device Name Product Code
    Stimulator, Nerve, For Restless Legs Syndrome QWD

    Proprietary Names

    NTX150 Tonic Motor Activation (NTX150 TOMAC) System NTX100 Tonic Motor Activation (NTX100 TOMAC) System Nidra Tonic Motor Activation (TOMAC) System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility