Data / Medical devices / Transcutaneous Nerve Stimulator For Adhd
Transcutaneous Nerve Stimulator For Adhd (QGL): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Transcutaneous Nerve Stimulator For Adhd (product code QGL, Class 2, 21 CFR 882.5898). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on January 16, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QGL
- Device class
- 2
- Regulation
- 882.5898
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| South Korea | 2 |
| United States | 1 |
| Malaysia | 1 |
Makers of Transcutaneous Nerve Stimulator For Adhd
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Neurosigma, Inc. | Los Angeles, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | January 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nu Eyne Co., Ltd. | Guro-gu Seoul, South Korea | Manufacturer | 2 | January 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bistos co., ltd. | Yongin-si Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 1 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Armstrong Electronics Sdn Bhd | Kulai Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.