SAVI Dual(TM) Migraine Therapy

GUDID 00816140020132

Patient use, Non-invasive, Central Neuromodulation Smart Device

ENEURA, INC.,

Home-use magnetic neural stimulator

• Primary Device ID: 00816140020132
• NIH Device Record Key: 6a3ac9d4-b013-4b73-82cf-4b52d4bbd96a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAVI Dual(TM) Migraine Therapy
• Version Model Number: DWG-0601
• Company DUNS: 013665656
• Company Name: ENEURA, INC.,
• 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: false
• 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	00816140020132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161663

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

Devices Manufactured by ENEURA, INC.,

• 00816140020132 - SAVI Dual(TM) Migraine Therapy: 2022-08-26Patient use, Non-invasive, Central Neuromodulation Smart Device
• 00816140020132 - SAVI Dual(TM) Migraine Therapy: 2022-08-26 Patient use, Non-invasive, Central Neuromodulation Smart Device
• 00816140020002 - SpringTMS: 2018-07-06 Transcranial Magnetic Stimulator Device
• 00816140020019 - SpringTMS: 2018-07-06 Transcranial Magnetic Stimulator Device
• 00816140020040 - SpringTMS: 2018-07-06 Transcranial Magnetic Stimulator Device Battery
• 00816140020071 - sTMS mini: 2018-07-06 Transcranial Magnetic Stimulator Device
• 00816140020088 - sTMS mini: 2018-07-06 Transcranial Magnetic Stimulator Device
• 00816140020095 - sTMS mini: 2018-07-06 Transcranial Magnetic Stimulator AC Adapter
• 00816140020101 - SpringTMS: 2018-07-06 Transcranial Magnetic Stimulator AC Adapter