LOTFANCY

GUDID 16973602730006

2''*2'' Electrodes

TOP-RANK HEALTH CARE CO., LTD.

Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current Transcranial electrical stimulation system, pulsed-current

• Primary Device ID: 16973602730006
• NIH Device Record Key: ede67fa9-639b-4bb4-a085-7babd058e990
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOTFANCY
• Version Model Number: 11M-2234-X
• Company DUNS: 529504164
• Company Name: TOP-RANK HEALTH CARE CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973602730009 [Primary]
GS1	16973602730006 [Package]; Contains: 06973602730009; Package: [4 Units]; In Commercial Distribution
GS1	20697360273003 [Package]; Package: [32 Units]; In Commercial Distribution

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-27

On-Brand Devices [LOTFANCY]

• 10697360273013: Adhesive Electrodes
• 16973602730006: 2''*2'' Electrodes
• 06973602730047: GEL PAD