NerivioInfinity
Basic Information
- Brand Name
- NerivioInfinity
- Primary DI
- 07290017578101
- Version / Model
- FGD000100
- Catalog Number
- FGD000100
- Company Name
- Theranica Bio-Electronics Ltd.
- Labeler DUNS
- 532352807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-20
- Public Version
- 1
- Public Version Date
- 2023-11-28
- Public Version Status
- New
- Public Device Record Key
- 729df0be-7bc6-42ca-b296-2eb0049a785d
Device Description
NerivioInfinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 12 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]). NerivioInfinity 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 electrodes are disposable and replaceable. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each. 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 the connection state and the remaining number of treatments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | Neurology | 882.5899 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60682 | Craniofacial analgesia electrical stimulator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017578101 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232152 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 80.6 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal