SpringTMS DWG-0096

GUDID 00816140020101

Transcranial Magnetic Stimulator AC Adapter

ENEURA, INC.,

Home-use magnetic neural stimulator Home-use magnetic neural stimulator Home-use magnetic neural stimulator

• Primary Device ID: 00816140020101
• NIH Device Record Key: 2f42f969-133f-4466-b44f-d66b7b4c25bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpringTMS
• Version Model Number: DWG-0096
• Catalog Number: DWG-0096
• Company DUNS: 013665656
• Company Name: ENEURA, INC.,
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(408)245-6400
• Email: Customercare@eneura.com
• Phone: +1(408)245-6400
• Email: Customercare@eneura.com
• Phone: +1(408)245-6400
• Email: Customercare@eneura.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816140020101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140094

FDA Product Code

• OKP: Transcranial magnetic stimulator for the treatment of migraine headache

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

On-Brand Devices [SpringTMS]

• 00816140020101: Transcranial Magnetic Stimulator AC Adapter
• 00816140020040: Transcranial Magnetic Stimulator Device Battery
• 00816140020019: Transcranial Magnetic Stimulator Device
• 00816140020002: Transcranial Magnetic Stimulator Device