FDA.reportPublic FDA data

USB to Electrical Stimulation Box Cable

Primary DI
00817020020310
Brand
USB to Electrical Stimulation Box Cable
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M014911
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
00817020020310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020310008170200203108170200203100817020020310

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
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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

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Primary DI, Brand, Company table
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08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
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