EMC EVOLUTION

Basic Information

• Brand Name: EMC EVOLUTION
• Primary DI: 03760265490394
• Version / Model: 112-B0-1-S
• Company Name: EMC EVOLUTION
• Labeler DUNS: 265981368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ab08e2c7-dcc2-4dac-bc11-23be53ce6b0c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	876.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36784	Perineal orifice incontinence-control electrical stimulation system	An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor. It consists of a pair of electrodes on a plug or pessary, and a pulse generator; it does not function by remote control. The plug or pessary is inserted into the rectum and/or the vagina to stimulate the pelvic floor muscles inducing Kegel-like contractions.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760265490394	GS1

Premarket Submissions

Submission Number	Supplement Number
K990041	000