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Nerivio

FDA UDI

Class II (US FDA UDI)

by Theranica Bio-Electronics, Ltd.

Identity

Trade Name
Nerivio FDA UDI
Generic Name
Craniofacial analgesia electrical stimulator FDA UDI
Device Name
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. FDA UDI
Model / Reference
FGD000075 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
07290017578019 FDA UDI
FDA Product Code
QGT FDA UDI
GMDN Term
Craniofacial analgesia electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5899 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Craniofacial analgesia electrical stimulator

Nerivio by Theranica Bio-Electronics, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial analgesia electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Theranica Bio-Electronics, Ltd.

Sources (1)

  • FDA UDI ed834e21-6c06-4638-bd08-c13c5a3cbf60 35 fields · synced Jun 1, 2026