Deep Transcranial Magnetic Stimulation (DTMS) System HEL-01200D-CPLX

GUDID 07290110530136

H1 Coil helmet with - for 104 system

BRAINSWAY LTD

Magnetic neural stimulation system

• Primary Device ID: 07290110530136
• NIH Device Record Key: 947f0f5e-733c-4529-9771-f70250e2c8cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deep Transcranial Magnetic Stimulation (DTMS) System
• Version Model Number: 104
• Catalog Number: HEL-01200D-CPLX
• Company DUNS: 531873441
• Company Name: BRAINSWAY 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110530136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173540

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: 2026-03-23
• Device Publish Date: 2026-03-14

On-Brand Devices [Deep Transcranial Magnetic Stimulation (DTMS) System]

• 07290110538248: Third arm for cart 104 - H7 coil
• 07290110538132: Upgrade kit arm H4 coil for 104 system
• 07290110538125: Deep TMS system 104 with H4
• 07290110538064: Upgrade kit – arm with H7 coil for 104 system
• 07290110538057: Upgrade kit arm with H1 coil for 104
• 07290110538040: Deep TMS 104 system with H7
• 07290110538026: Deep TMS system 104 with H1 coil
• 07290110537234: Third arm for cart 104 - H1 coil
• 07290110537197: Third arm for cart 104 - H4 coil
• 07290110533113: Patient Cap Kit (XL)
• 07290110533106: Patient Cap Kit (S)
• 07290110533090: Patient Cap Kit (M)
• 07290110533083: Patient Cap Kit (L)
• 07290110530204: H4 Coil helmet - for 104 system
• 07290110530167: H7 Coil helmet - for 104 system
• 07290110530136: H1 Coil helmet with - for 104 system