QGT
7 FDA 510(k) clearances · Product code
112 daysmedian time to decision
195 days90th percentile
7clearances measured
FDA profile
- Official device name
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5899
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Nerivio; Nerivio Infinity (K250405) | Theranica Bio-Electronics, Ltd. | 2025-05-14 |
| Nerivio; NerivioInfinity (K241756) | Theranica Bio-Electronics, Ltd. | 2024-10-08 |
| NerivioInfinity (K232152) | Theranica Bioelectronics , Ltd. | 2023-11-08 |
| Nerivio (K223169) | Theranica Bioelectronics , Ltd. | 2023-02-06 |
| Nerivio, FGD000075-4.7 (K203181) | Theranica Bioelectronics , Ltd. | 2021-01-22 |
| Nerivio (K201824) | Theranica Bio-Electronics, Ltd. | 2020-10-23 |
| Nerivio Migra (DEN180059) | Theranica Bioelectronics , Ltd. | 2019-05-20 |
Track QGT automatically
Every clearance here is in the API, with alerts when new ones post.