BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTELLIGENT HEARING SYSTEMS CORP.

    Reg #: 1052723 · FEI: 1000113738 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    24
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    INTELLIGENT HEARING SYSTEMS CORP.
    Registration Number
    1052723
    FEI Number
    1000113738
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6860 Sw 81st St
    City
    MIAMI
    State
    FL
    ZIP
    33143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063402

    Owner / Operator

    Firm Name
    INTELLIGENT HEARING SYSTEMS
    Operator Number
    9000078
    Address
    6860 S.W. 81ST ST., --
    City
    Miami
    State
    FL
    Postal Code
    33143
    Country
    US
    Correspondent
    EDWARD - MISKIEL

    Products

    Device Name Product Code
    Stimulator, Auditory, Evoked Response GWJ
    Electrode, Cutaneous GXY
    Stimulator, Nerve ETN
    Stimulator, Photic, Evoked Response GWE
    Stimulator, Electrical, Evoked Response GWF
    Cable, Electrode IKD
    Audiometer EWO
    Amplifier, Physiological Signal GWL

    Proprietary Names

    Lilly TM-Wick Electrode EarHug SmartEP (Somatosensory Package) SmartEP (Visual EP Package) Universal Smart Box SmartAudiometer Smart USBLite USB Jr Duet USBLite Solo Aria SmartEP (VEMP) SmartEP SmartOAE SmartDPOAE Smart TrOAE SmartEP-ASSR OptiAmp MADSEN Capella2 DP/TE/DP+TE Intelligent VRA IVRA Smart EP SmartScreener-Plus2 UBS Jr Duet Opti-Amp DC Powered

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only