Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
The Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine is a device intended to treat headache through the application of electrical stimulation on the body of the patient, specifically anywhere apart from the head or neck, through electrodes placed on the skin (transcutaneously or percutaneously), for acute migraine treatment. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.5899 in the Neurology specialty. The product code is QGT. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGT
- Device Class
- FDA class 2
- Regulation Number
- 882.5899
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250405 | Nerivio; Nerivio Infinity | May 14, 2025 | Substantially Equivalent | Theranica Bio-Electronics, Ltd. |
| K241756 | Nerivio; NerivioInfinity | Oct 08, 2024 | Substantially Equivalent | Theranica Bio-Electronics, Ltd. |
| K232152 | NerivioInfinity | Nov 08, 2023 | Substantially Equivalent | Theranica Bioelectronics , Ltd. |
| K223169 | Nerivio | Feb 06, 2023 | Substantially Equivalent | Theranica Bioelectronics , Ltd. |
| K203181 | Nerivio, FGD000075-4.7 | Jan 22, 2021 | Substantially Equivalent | Theranica Bioelectronics , Ltd. |
| K201824 | Nerivio | Oct 23, 2020 | Substantially Equivalent | Theranica Bio-Electronics, Ltd. |
| DEN180059 | Nerivio Migra | May 20, 2019 | Unknown | Theranica Bioelectronics , Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.