Coil Arm

GUDID 06971538580316

Shenzhen Yingzhi Technology Co.,Ltd.

Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley

• Primary Device ID: 06971538580316
• NIH Device Record Key: 05e41ba7-6e22-49b9-b972-5803913a232c
• Commercial Distribution Discontinuation: 2023-12-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Coil Arm
• Version Model Number: Universal
• 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	06971538580316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230735

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

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
• 06971538580156 - TMS Coil Cooler: 2023-12-29
• 06971538580163 - TMS Coil Cooler: 2023-12-29
• 06971538580286 - Positioning Cap: 2023-12-29