nerivio.comNerivio
Theranica Bio-Electronics LTD.
THERANICA BIO-ELECTRONICS LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015379717 | 3015379717 | THERANICA BIO-ELECTRONICS LTD. | 1 | N | 2026-01-01 | 9 Granit st., North Industrial Park Caesarea Central IL 3079893 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290017578019 | Nerivio - 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. | (937) 637-4846 | support@nerivio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 231236 | 1190108500 | K250405 | Nerivio; Nerivio Infinity | QGT | 2025-05-14 |
| 231236 | 1154301920 | K232152 | NerivioInfinity | QGT | 2023-11-08 |
| 231236 | 1272613799 | DEN180059 | Nerivio Migra | QGT | 2019-05-20 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QGT | 3 | 2025-05-14 |
PMN#
GUDID#
Nerivio Infinity - Nerivio Infinity 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 Infinity 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 Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each.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.The Nerivio Infinity package under this UDI contains 1 refill unit.
2024-06-20
Nerivio Infinity - Nerivio Infinity 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 Infinity 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 Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each.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.The Nerivio Infinity package under this UDI contains 3 refill units.
2023-11-20
Nerivio Infinity Refill - 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.
2023-11-20
Nerivio - Refill pack for Nerivio device
2022-01-10
Nerivio - 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.
2019-09-10