QGT — Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine Class II
FDA product code QGT covers "Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine", a Class II medical device regulated under 21 CFR 882.5899. Submissions are reviewed by the Neurology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QGT
- Device Class
- Class II
- Regulation Number
- 882.5899
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250405 | theranica bio-electronics | Nerivio; Nerivio Infinity | May 14, 2025 |
| K241756 | theranica bio-electronics | Nerivio; NerivioInfinity | October 8, 2024 |
| K232152 | theranica bioelectronics | NerivioInfinity | November 8, 2023 |
| K223169 | theranica bioelectronics | Nerivio | February 6, 2023 |
| K203181 | theranica bioelectronics | Nerivio, FGD000075-4.7 | January 22, 2021 |
| K201824 | theranica bio-electronics | Nerivio | October 23, 2020 |
| DEN180059 | theranica bioelectronics | Nerivio Migra | May 20, 2019 |