BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOUND HEALTH SYSTEMS, INC.

    Reg #: 3030266327 · FEI: 3030266327 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SOUND HEALTH SYSTEMS, INC.
    Registration Number
    3030266327
    FEI Number
    3030266327
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3031 Tisch Way, 110 Plaza West, Suite #1068
    City
    San Jose
    State
    CA
    ZIP
    95128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242214

    Owner / Operator

    Firm Name
    Sound Health Systems, Inc.
    Operator Number
    10089787
    Address
    3031 Tisch Way, 110 Plaza West, Suite #1068
    City
    San Jose
    State
    CA
    Postal Code
    95128
    Country
    US
    Correspondent
    Kondapavulur Venkateswara-Rao

    Products

    Device Name Product Code
    External Mechanical Stimulator For The Relief Of Congestion QZC

    Proprietary Names

    Sonu Headband - Black (Model SHS-HW-001B) Sonu Headband - Gray (Model SHS-HW-001A)

    Establishment Types

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