eCoin External Controller Kit

Basic Information

• Brand Name: eCoin External Controller Kit
• Primary DI: 00860007896972
• Version / Model: 1011-5436
• Catalog Number: 1011-5436
• Company Name: Valencia Technologies Corporation
• Labeler DUNS: 968538988
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-27
• Public Version: 1
• Public Version Date: 2023-05-05
• Public Version Status: New
• Public Device Record Key: 6a04c0d9-e18a-45c8-ae89-35ef549a4c95

Device Description

eCoin External Controller Kit

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
QPT	Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64780	Tibial nerve implantable incontinence-control electrical stimulation system	An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the sacral plexus via tibial nerve stimulation. It consists of an electrode implanted in the vicinity of the tibial nerve, an external transcutaneous pulse generator attached to the leg, and an external programmer/transmitter that communicates with the pulse generator.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007896972	GS1

Premarket Submissions

Submission Number	Supplement Number
P200036	005