Relivion MG App

GUDID 07290018393147

An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment

NEUROLIEF LTD

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• Primary Device ID: 07290018393147
• NIH Device Record Key: b4e04d98-ae2d-4dd3-aa0d-2965c5e4de53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relivion MG App
• Version Model Number: RLV-PMI-102
• 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: 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
GS1	07290018393147 [Primary]

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: 2021-12-27
• Device Publish Date: 2021-12-19

Devices Manufactured by NEUROLIEF LTD

• 07290018393130 - Relivion MG PMI Physician Interface: 2021-12-27 A cloud-based Patient Management Interface (PMI Physician Interface and cloud platform)
• 07290018393147 - Relivion MG App: 2021-12-27An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
• 07290018393147 - Relivion MG App: 2021-12-27 An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usa
• 17290018393113 - Relivion: 2021-12-13 Relivion is a non-invasive medical device. It transfers mild electrical pulses to branches of the Trigeminal (Supraorbital and S
• 17290018393014 - Relivion: 2021-12-13 Electrode Pad Set