K243289 is an FDA 510(k) clearance for the ADDNOX (BPSPM1). This device is classified as a Transcutaneous Nerve Stimulator For Adhd (Class II - Special Controls, product code QGL).
Submitted by Nu Eyne Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 16, 2025, 90 days after receiving the submission on October 18, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5898. A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead..
| 510(k) Number | K243289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QGL - Transcutaneous Nerve Stimulator For Adhd |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5898 |
| Definition | A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead. |