Nerivio
GUDID 07290017578019
Nerivio is a wireless remote electrical neuromodulation device for the acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. 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. 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) 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 connection state and remaining number of treatments.
Theranica Bio-Electronics Ltd.
Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator| Primary Device ID | 07290017578019 |
| NIH Device Record Key | ed834e21-6c06-4638-bd08-c13c5a3cbf60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nerivio |
| Version Model Number | FGD000075 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com |
Operating and Storage Conditions
| 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 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 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017578019 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN180059
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 | 2019-09-18 |
| Device Publish Date | 2019-09-10 |
On-Brand Devices [Nerivio]
| 07290017578019 | Nerivio is a wireless remote electrical neuromodulation device for the acute treatment of migrai |
| 07290017578026 | Refill pack for Nerivio device |
Trademark Results [Nerivio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NERIVIO 79270961 not registered Live/Pending |
THERANICA BIO-ELECTRONICS LTD. 2019-08-06 |
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