LOTFANCY

Basic Information

• Brand Name: LOTFANCY
• Primary DI: 06973602730016
• Version / Model: 11M-2229-S
• Company Name: TOP-RANK HEALTH CARE CO., LTD.
• Labeler DUNS: 529504164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-27
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 44d3615d-2f3d-4c32-9bac-d27fbf4978b3

Device Description

Adhesive Electrodes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31268	Transcranial electrical stimulation system, pulsed-current	A noninvasive assembly of mains electricity (AC-powered) devices designed to apply weak, pulsed (not continuous) electrical stimuli to a patient's brain to treat one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction; it may also be intended to induce a state resembling that of chemically-induced anaesthesia. It usually includes an electrical pulse generator with controls to vary the pulse rate, pulse width, and voltage or current, with the current applied via leads and appropriate scalp electrodes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10697360273013	GS1		12	In Commercial Distribution
Primary	06973602730016	GS1
Package	20697360273010	GS1		96	In Commercial Distribution