FDA.reportPublic FDA data

USBLite Solo

Primary DI
00817020020136
Brand
USBLite Solo
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M011140
Published
2017-01-17
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
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061443000SMART USBLITE, MODEL M011120Intelligent Hearing Systems2006-06-23GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020136008170200201368170200201360817020020136

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.

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
00817020021126AriaM0111602024-03-11
00817020020013EarHug PackM0154022016-09-24
00817020020358Sound Field Connector to Amp Cable (Mono Plugs)M0257012016-09-24
00817020020365Sound Field Output Cable to Amplifier (RCA Plugs)M0257042016-09-24
00817020029931Capella2 Starter Kit8-69-428002018-11-07
00817020029948EarHugs for AccuScreenM0154112016-09-24
00817020020006EarHugM0154012016-09-24
00817020020945EarHug Pack - No ElectrodesM0154042017-01-30
00817020020037Lilly TM-Wick ElectrodeM0139102016-09-24
00817020020877SmartAudiometer SoftwareM8170002016-09-24
00817020021058Bone Vibrator w/ Cable and Headband (B81)M0144042021-02-10
00817020021065DD45-300 HeadphonesM0150532021-02-10
00817020020617Bone Vibrator Cable for USBLiteM0144112016-09-24
00817020020624Bone Vibrator 300 OhmsM0144002016-09-24
00817020020631Bone Vibrator CableM0144102016-09-24
00817020020648Bone Vibrator Head BandM0144202016-09-24
00817020020655Bone Vibrator Peidatric Head BandM0144302016-09-24
00817020020808SmartEP SoftwareM8110002016-09-24
00817020020815SmartEP-ASSR SoftwareM8110072016-09-24
00817020020822SmartScreener-Plus2 Screener LaunchM8120022016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWL2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWL2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWL2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.GWJ2024-03-11
18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14
18437017440632Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14
18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14
18436612823031Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14
18436612823048Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14
18436612823055Enobio DxNEUROELECTRICS BARCELONA SLGWL2023-09-14