Treatment Chair

GUDID 06971538580309

Shenzhen Yingzhi Technology Co.,Ltd.

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• Primary Device ID: 06971538580309
• NIH Device Record Key: 66968bbb-f91b-4422-84e6-caf0146e0300
• Commercial Distribution Discontinuation: 2023-12-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Treatment Chair
• 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	06971538580309 [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.

• 06971538581047 - TMS Coil: 2024-06-24 Double cone TMS coil, liquid cooling
• 06971538581054 - TMS Coil: 2024-06-24 Figure-8 TMS coil, liquid cooling
• 06971538581061 - TMS Coil: 2024-06-24 Figure-8 TMS coil, liquid cooling with angle
• 06971538581078 - TMS Coil: 2024-06-24 Figure-8 TMS coil, air cooling
• 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