FDA.reportPublic FDA data

EarHug Pack

Primary DI
00817020020013
Brand
EarHug Pack
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M015402
Device description
25 pair of EarHugs and three packs of Ambu Neuroline (25x) 720 electrodes
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K090579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090579000SMARTSCREENER-PLUS2Intelligent Hearing Systems2009-07-07GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020013008170200200138170200200130817020020013

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Regulatory Flags#

DUNS number
154870455
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04260223147753Ear Coupler TR 30 pairsPATH medical GmbHGWJ2026-07-29
05711117244540InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244557InteracousticsInteracoustics A/SGWJ2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
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