Headrest

GUDID B108699HEADRESTMEU00

BTL INDUSTRIES LIMITED

Magnetic neural stimulation system

• Primary Device ID: B108699HEADRESTMEU00
• NIH Device Record Key: 95dcf50b-d16a-41eb-8ad2-3ad191e452a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headrest
• Version Model Number: Headrest
• Company DUNS: 733532951
• Company Name: BTL INDUSTRIES LIMITED
• 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: 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
HIBCC	B108699HEADRESTMEU00 [Primary]

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: 2024-11-14
• Device Publish Date: 2024-11-06

Devices Manufactured by BTL INDUSTRIES LIMITED

• B108699BELTMEU00 - Belt: 2024-11-14
• B108699HEADRESTMEU00 - Headrest: 2024-11-14
• B108699HEADRESTMEU00 - Headrest: 2024-11-14
• B108899PO11C1ENUS0150 - EMSCULPT NEO: 2024-10-01
• B108699APM2MUS00 - EXOMIND applicator: 2024-09-05
• B108699PO2M2MUS00 - EXOMIND: 2024-09-05
• B108043PO30WMUS00 - LS-6000: 2024-04-01
• B108451POSCAEL2MUS00 - Scanning System for LS-6000: 2024-04-01
• B108899AP2C2MUS20 - Small applicator: 2023-12-18