DEVICE: Nerivio (07290017578019)
Device Identifier (DI) Information
Nerivio
FGD000075
In Commercial Distribution
Theranica Bio-Electronics Ltd.
FGD000075
In Commercial Distribution
Theranica Bio-Electronics Ltd.
Nerivio is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 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]).
Nerivio is a wireless wearable battery-operated device controlled by a mobile software application. The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60682 | Craniofacial analgesia electrical stimulator |
A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 50 and 80.6 Degrees Fahrenheit |
Storage Environment Humidity: between 40 and 50 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ed834e21-6c06-4638-bd08-c13c5a3cbf60
October 11, 2024
4
September 10, 2019
October 11, 2024
4
September 10, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(937) 637-4846
support@nerivio.com
support@nerivio.com