NeoControl

Basic Information

• Brand Name: NeoControl
• Primary DI: 00864618000308
• Version / Model: N-0228-F-220VAC
• Company Name: MAGIC RACE LLC
• Labeler DUNS: 080456235
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-08
• Public Version: 3
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: 87fad0c1-0c0e-48be-a256-36a6961d3e06

Device Description

Control Unit, 220 volt, NeoControl Pelvic Floor Therapy System

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: No
• 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
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	876.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46571	Physical therapy transcutaneous electrical stimulation system, line-powered	An assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864618000308	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]