Relivion

GUDID 17290018393113

Relivion is a non-invasive medical device. It transfers mild electrical pulses to branches of the Trigeminal (Supraorbital and Supratrochlear) and Occipital nerves to treat headaches.

NEUROLIEF LTD

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• Primary Device ID: 17290018393113
• NIH Device Record Key: b57991af-8a4e-488d-8ad7-410c90abed04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relivion
• Version Model Number: RLV3
• Company DUNS: 600484465
• Company Name: NEUROLIEF 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: 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	07290018393000 [Primary]
GS1	17290018393113 [Package]; Contains: 07290018393000; Package: Cardboard Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212106

FDA Product Code

• PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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: 2021-12-13
• Device Publish Date: 2021-12-05

On-Brand Devices [Relivion]

• 17290018393014: Electrode Pad Set
• 17290018393113: Relivion is a non-invasive medical device. It transfers mild electrical pulses to branches of th