BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Nidra Tonic Motor Activation (TOMAC) System

    Reg #: 9710609 · FEI: 3003202721 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RACER TECHNOLOGY PTE LTD
    Registration Number
    9710609
    FEI Number
    3003202721
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28 CHANGI SOUTH ST. 1
    City
    SINGAPORE South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    DEN220059

    Owner / Operator

    Firm Name
    RACER TECHNOLOGY PTE LTD
    Operator Number
    9047394
    Address
    No. 28, Changi South St. 1
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    486772
    Country
    SG

    US Agent

    Business Name
    REGISTRAR CORP
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    HAMPTON
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)