FDA.reportPublic FDA data

Feedback Box

Primary DI
00817020020426
Brand
Feedback Box
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M025500D
Device description
Feedback Box for use with USB Jr Duet
Published
2017-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163326000SmartEPIntelligent Hearing Systems2017-09-29GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020426008170200204268170200204260817020020426

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback systemAn assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154870455
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817020020723Screener CartM998920S2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetM0131532026-06-10
00817020021027Toy Cabinet (Small)M025400S2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)M0111142026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandM0150562026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandM0150572026-06-10
00817020021119Reusable Safety Snap Leads 40" (3) for Duet/Aria/SoloM013933S2026-06-10
00817020021133OAE Probe OP23M0322002026-06-10
00817020021140Diagnostic CartM998920D2026-06-10
00817020021218DD450 HF HeadphonesM0150602026-06-10
00817020021225DD45S (10 Ohms) HeadphonesM0150802026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandM0150812026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandM0150822026-06-10
00817020020280Capella2 OAE Start-Up Kit8-69-428002026-06-09
00817020021003B81 Bone VibratorM0144022026-06-09
00817020021010B81 Bone Vibrator CableM0144032026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaM0144052026-06-09
00817020021171Bone Vibrator Cable for AriaM0144062026-06-09
00817020020044Lilly TM-Wick Electrode CableM0139142016-09-24
00817020020068eABR Cable for USB Jr DuetM0131522016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.GWJ2024-03-11
00627908020178EP HeadphonesVivosonic IncGWJ2023-06-08
00627908020185ECochG AdaptersVivosonic IncGWJ2023-06-08
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWJ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWJ2023-04-19
00195278524089NAGE Healthcare Finland OyGWJ2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyGWJ2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyGWJ2022-07-01
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWJ2020-05-25
00382830045247Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045278Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045292Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20