FDA UDI
In Commercial Distribution
🇺🇸 United States
NerivioInfinity Electrodes Kit
DI: 07290017578200
·
Model: FGD000110
·
Theranica Bio-Electronics Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NerivioInfinity Electrodes Kit
- Primary DI
- 07290017578200
- Version / Model
- FGD000110
- 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
- 5eb70457-1bfd-4f3f-a3c5-5c192fce7c58
Device Description
The NerivioInfinity Electrodes kit is a disposable and replaceable electrodes pad (one pair of electrodes) that connects to the NerivioInfinity by two metal pins located at the inner side of the pad, that fit the sockets on the NerivioInfinity device. The outer side of the pad is in contact with the skin and transfers the electrical current from the device to the body during the treatment. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 | 07290017578200 | 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