QGT
- Product code
- QGT
- Device name
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5899
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
FDA classification definition
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K250405 | 2025-05-14 | Theranica Bio-Electronics, Ltd. | Nerivio; Nerivio Infinity summary |
| K241756 | 2024-10-08 | Theranica Bio-Electronics, Ltd. | Nerivio; NerivioInfinity summary |
| K232152 | 2023-11-08 | Theranica Bioelectronics , Ltd. | NerivioInfinity summary |
Official FDA classification page: QGT
Classification and pathway per current FDA publications. Data from openFDA (CC0).