NerivioInfinity FGD000100

GUDID 07290017578101

NerivioInfinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). NerivioInfinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The electrodes are disposable and replaceable. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each. The application has a graphical user interface (GUI) which includes graphical controls that the user can select using a touch screen. Activating the stimulation, controlling the stimulation intensity, monitoring the treatment duration, and pausing and terminating the stimulation are performed by this application. The application also provides notifications and indications on the connection state and the remaining number of treatments.

Theranica Bio-Electronics Ltd.

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• Primary Device ID: 07290017578101
• NIH Device Record Key: 729df0be-7bc6-42ca-b296-2eb0049a785d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NerivioInfinity
• Version Model Number: FGD000100
• Catalog Number: FGD000100
• 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: 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

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	07290017578101 [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.

• 07290017578101 - NerivioInfinity: 2023-11-28NerivioInfinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). NerivioInfinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The electrodes are disposable and replaceable. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each. The application has a graphical user interface (GUI) which includes graphical controls that the user can select using a touch screen. Activating the stimulation, controlling the stimulation intensity, monitoring the treatment duration, and pausing and terminating the stimulation are performed by this application. The application also provides notifications and indications on the connection state and the remaining number of treatments.
• 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: 2023-11-28 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