Nerivio

Primary DI
07290017578019
Brand
Nerivio
Company
Theranica Bio-Electronics Ltd.
Model
FGD000075
Device 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.
Published
2019-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute MigraineNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180059000Nerivio MigraTheranica Bioelectronics , Ltd.2019-05-20QGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017578019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017578019072900175780197290017578019

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial analgesia electrical stimulatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity40 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit80.6 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(937) 637-4846support@nerivio.com

Regulatory Flags#

DUNS number
532352807
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017578118Nerivio InfinityFGD000100FGD0001002024-06-20
07290017578101Nerivio InfinityFGD000100FGD0001002023-11-20
07290017578200Nerivio Infinity Refill FGD0001102023-11-20
07290017578026NerivioFGD0000752022-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017578118Nerivio InfinityTheranica Bio-Electronics Ltd.QGT2024-06-20
07290017578101Nerivio InfinityTheranica Bio-Electronics Ltd.QGT2023-11-20
07290017578200Nerivio Infinity Refill Theranica Bio-Electronics Ltd.QGT2023-11-20
07290017578026NerivioTheranica Bio-Electronics Ltd.QGT2022-01-10