BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HELIUS MEDICAL, INC

    Reg #: 3015259856 · FEI: 3015259856 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    HELIUS MEDICAL, INC
    Registration Number
    3015259856
    FEI Number
    3015259856
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    642 Newtown Yardley Rd., Suite 100
    City
    Newtown
    State
    PA
    ZIP
    18940
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200050

    Owner / Operator

    Firm Name
    Helius Medical, Inc
    Operator Number
    10059664
    Address
    642 Newtown Yardley Rd., Suite 100
    City
    Newtown
    State
    PA
    Postal Code
    18940
    Country
    US
    Correspondent
    Lawrence Picciano

    Products

    Device Name Product Code
    Electrical Tongue Stimulator To Treat Motor Deficits QCF

    Proprietary Names

    Portable Neuromodulation Stimulator (PoNS)

    Establishment Types

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