INTELLIGENT HEARING SYSTEMS CORP.

FDA Device Registration & Listing · MIAMI, FL, US · Registration 1052723

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1052723
FEI Number
1000113738
Entity Name
INTELLIGENT HEARING SYSTEMS CORP.
City/State/Country
MIAMI, FL, US
Establishment Address
6860 Sw 81st St, MIAMI, FL 33143, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
INTELLIGENT HEARING SYSTEMS (Owner Number: 9000078)
Owner / Operator Contact Address
6860 S.W. 81ST ST., --, Miami, FL 33143, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Universal Smart Box Aria SmartEP (VEMP) SmartEP Universal Smart Box SmartEP (Visual EP Package) SmartEP (Somatosensory Package) Aria USB Jr Duet SmartOAE USB Jr Duet SmartDPOAE Universal Smart Box Aria Smart USBLite USB Jr Duet Smart USBLite Aria Universal Smart Box Smart TrOAE SmartEP-ASSR USB Jr Duet Universal Smart Box Aria USBLite Solo Smart USBLite OptiAmp

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2020-05-26
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2007-11-05
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2008-10-16
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2009-10-29
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2009-10-29
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2009-10-29
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2009-10-29
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2016-09-21
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 1992-07-08
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2017-10-05
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2017-10-05
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2017-10-05
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2017-10-05
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2007-11-05
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2007-11-05
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2007-11-05
GWL Amplifier, Physiological Signal Neurology Class 2 882.1835 2007-11-05
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2020-10-08

Official Correspondent

EDWARD MISKIEL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTELLIGENT HEARING SYSTEMS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1052723. Last updated year: 2026. Please use registration number 1052723 when referencing this establishment in official correspondence.
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