USB to Electrical Stimulation Box Cable

Basic Information

• Brand Name: USB to Electrical Stimulation Box Cable
• Primary DI: 00817020020310
• Version / Model: M014911
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• Labeler DUNS: 154870455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3de110a2-5514-4dd6-8b49-68d7715a574f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWF	Stimulator, Electrical, Evoked Response	Neurology	882.1870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35726	Somatosensory electrical stimulation system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817020020310	GS1

Premarket Submissions

Submission Number	Supplement Number
K070608	000