FDA.reportPublic FDA data

Electrical Stimulator Probe

Primary DI
00817020020303
Brand
Electrical Stimulator Probe
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M014920
Published
2016-09-24
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
GWFStimulator, Electrical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070608000SMARTEP, MODEL M010000Intelligent Hearing Systems2007-07-18GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817020020303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020303008170200203038170200203030817020020303

GMDN Terms#

Term, Definition table
TermDefinition
Somatosensory electrical stimulation systemAn assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.

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
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
00817020020075USB Jr DuetM0103002016-09-24
00817020020273OAE 10D ProbeM0321032016-09-24
00817020020594ER-3C Insert Earphones (300Ohms) for Solo/AriaM015302S2017-01-17
00817020020624B71 Bone VibratorM0144002016-09-24
00817020020808SmartEP SoftwareM8110002016-09-24
00817020020877SmartAudiometer SoftwareM8170002016-09-24
00817020020952USB Jr Duet Response BoxM031501D2017-01-30
00817020029993OAE 10D ProbeM032103G2018-05-14
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

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Primary DI, Brand, Company table
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08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
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08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
00190376530024SafeOp 3ALPHATEC SPINE, INC.GWF2024-11-12
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