FDA product code QGT: 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. It is a Class II device, regulated under 21 CFR 882.5899 and reviewed by the Neurology panel. FDA has cleared 6 510(k) submissions under QGT, 4 in the last five years, from 2 different applicants. The average 510(k) review took 106 days (median 112); 101 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QGT devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine |
| Device class | Class II |
| Regulation | 21 CFR 882.5899 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QGT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 114 |
| 2021 | 1 | 88 |
| 2023 | 2 | 115 |
| 2024 | 1 | 112 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every QGT clearance
Top QGT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Theranica Bio-Electronics, Ltd. | 3 | 2025-05-14 |
| Theranica Bioelectronics , Ltd. | 3 | 2023-11-08 |
Most recent QGT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250405 | Theranica Bio-Electronics, Ltd. | Nerivio; Nerivio Infinity | 2025-05-14 | 90 |
| K241756 | Theranica Bio-Electronics, Ltd. | Nerivio; NerivioInfinity | 2024-10-08 | 112 |
| K232152 | Theranica Bioelectronics , Ltd. | NerivioInfinity | 2023-11-08 | 112 |
| K223169 | Theranica Bioelectronics , Ltd. | Nerivio | 2023-02-06 | 118 |
| K203181 | Theranica Bioelectronics , Ltd. | Nerivio, FGD000075-4.7 | 2021-01-22 | 88 |
Recalls for QGT devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-23.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code QGT?
QGT is the FDA product code for distal transcutaneous electrical stimulator for treatment of acute migraine. It is a Class II device, regulated under 21 CFR 882.5899 and reviewed by the Neurology panel.
What device class is QGT?
Class II, regulation 21 CFR 882.5899. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGT?
Across 6 cleared submissions the average was 106 days from receipt to decision (median 112).
Which companies have the most QGT clearances?
Theranica Bio-Electronics, Ltd. (3); Theranica Bioelectronics , Ltd. (3).
Have QGT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code QGT
- Run a recall and safety report across every QGT manufacturer
- Watch product code QGT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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