TMS Coil

GUDID 06971538580149

Shenzhen Yingzhi Technology Co.,Ltd.

Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system

• Primary Device ID: 06971538580149
• NIH Device Record Key: 5a077bca-3712-4ab9-9722-102172ab6657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMS Coil
• Version Model Number: /
• Company DUNS: 560014166
• Company Name: Shenzhen Yingzhi Technology 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971538580149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230735

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2023-12-29
• Device Publish Date: 2023-12-21

Devices Manufactured by Shenzhen Yingzhi Technology Co.,Ltd.

• 06971538580019 - Ultimate rTMS: 2024-01-24 Stimulator
• 06971538580033 - Ultimate rTMS: 2024-01-24 Stimulator
• 06971538580026 - Ultimate rTMS: 2023-12-29 Stimulator
• 06971538580040 - Ultimate rTMS: 2023-12-29
• 06971538580149 - TMS Coil: 2023-12-29
• 06971538580149 - TMS Coil: 2023-12-29
• 06971538580156 - TMS Coil Cooler: 2023-12-29
• 06971538580163 - TMS Coil Cooler: 2023-12-29
• 06971538580286 - Positioning Cap: 2023-12-29