Transcutaneous Nerve Stimulator For Adhd
Regulation 882.5898
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QGL
| Company | 510(k)s | Recalls |
|---|---|---|
| Neurosigma, Inc. | 2 | 0 |
| Nu Eyne Co., Ltd. | 2 | 0 |
| Bistos Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2025 | K243289 | ADDNOX (BPSPM1) Nu Eyne Co., Ltd., KR | QGL |
| Aug 28, 2024 | K232991 | BT-1000 Bistos Co., Ltd., KR | QGL |
| Jan 16, 2024 | K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® Neurosigma, Inc. | QGL |
| Feb 12, 2023 | K213629 | SMILE Nu Eyne Co., Ltd., KR | QGL |
| Apr 19, 2019 | DEN180041 | Monarch eTNS System Neurosigma, Inc. | QGL |
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