BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neuronetics Inc.

    Reg #: 3004824012 · FEI: 3004824012 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Neuronetics Inc.
    Registration Number
    3004824012
    FEI Number
    3004824012
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3222 Phoenixville Pike
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130233

    Owner / Operator

    Firm Name
    Neuronetics Inc
    Operator Number
    10027686
    Address
    3222 Phoenixville Pike
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Alexandra Williamson

    Products

    Device Name Product Code
    Transcranial Magnetic Stimulator OBP
    Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder QCI

    Proprietary Names

    NeuroStar TMS Therapy System NeuroStar Advanced Therapy NeuroStar Advanced Therapy System Head Side Pad SenStar Connect Treatment Link Wedge Cushion NeuroStar System Software SenStar Treatment Link Head Insert Cushion Arm Support Cushion NeuroStar TMS Therapy System Laser Positioning Aid NeuroStar Head Support System MT Cap D-Tect MT Accessory TrakStar Patient Data Management System OCD MT Cap NeuroSITE NeuroStar Headrest

    Establishment Types

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