NerivioInfinity Electrodes Kit

GUDID 07290017578200

The NerivioInfinity Electrodes kit is a disposable and replaceable electrodes pad (one pair of electrodes) that connects to the NerivioInfinity by two metal pins located at the inner side of the pad, that fit the sockets on the NerivioInfinity device. The outer side of the pad is in contact with the skin and transfers the electrical current from the device to the body during the treatment. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each.

Theranica Bio-Electronics Ltd.

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• Primary Device ID: 07290017578200
• NIH Device Record Key: 5eb70457-1bfd-4f3f-a3c5-5c192fce7c58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NerivioInfinity Electrodes Kit
• Version Model Number: FGD000110
• Company DUNS: 532352807
• Company Name: Theranica Bio-Electronics Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017578200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232152

FDA Product Code

• QGT: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute 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: 2023-11-28
• Device Publish Date: 2023-11-20

Devices Manufactured by Theranica Bio-Electronics Ltd.

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• 07290017578101 - NerivioInfinity: 2023-11-28 NerivioInfinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migrai
• 07290017578200 - NerivioInfinity Electrodes Kit: 2023-11-28The NerivioInfinity Electrodes kit is a disposable and replaceable electrodes pad (one pair of electrodes) that connects to the NerivioInfinity by two metal pins located at the inner side of the pad, that fit the sockets on the NerivioInfinity device. The outer side of the pad is in contact with the skin and transfers the electrical current from the device to the body during the treatment. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each.
• 07290017578200 - NerivioInfinity Electrodes Kit: 2023-11-28 The NerivioInfinity Electrodes kit is a disposable and replaceable electrodes pad (one pair of electrodes) that connects to the
• 07290017578026 - Nerivio: 2022-01-18 Refill pack for Nerivio device
• 07290017578019 - Nerivio: 2019-09-18 Nerivio is a wireless remote electrical neuromodulation device for the acute treatment of migraine with or without aura in patie