Nerivio Infinity Refill

Primary DI
07290017578200
Brand
Nerivio Infinity Refill
Company
Theranica Bio-Electronics Ltd.
Model
FGD000110
Device description
The Nerivio Infinity Reffil t is a disposable and replaceable unit. It connects to the Nerivio Infinity device by two metal pins located on the inner side of the unit that fit the sockets on the device. The outer side of the unit comes in contact with the skin and transfers the electrical current from the device to the body during the treatment. The refill unit is sufficient for up to 18 treatments of 45 minutes each.The Nerivio Infinity refill unit is equipped with a Near-Field Communication (NFC) chip, to ensure control and authenticity.
Published
2023-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
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
K232152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232152000NerivioInfinityTheranica Bioelectronics , Ltd.2023-11-08QGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017578200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017578200072900175782007290017578200

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 Humidity60 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
937-6374846support@nerivio.com

Regulatory Flags#

DUNS number
532352807
Device count
1
Lot or batch
true
Manufacturing date on label
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
07290017578026NerivioFGD0000752022-01-10
07290017578019NerivioFGD0000752019-09-10

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
07290017578026NerivioTheranica Bio-Electronics Ltd.QGT2022-01-10
07290017578019NerivioTheranica Bio-Electronics Ltd.QGT2019-09-10