Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QGT is the FDA product code for Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine, a class II device type, regulated under 21 CFR 882.5899. FDA's definition for this code reads: "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...". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- QGT
- Device name
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- 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.
- Regulation
- 21 CFR 882.5899
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 1
Clearances, product code QGT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code QGT| Applicant | Clearances |
|---|---|
| Theranica Bio-Electronics Ltd. | 7 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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