K213629 is an FDA 510(k) clearance for the SMILE. 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 February 12, 2023, 452 days after receiving the submission on November 17, 2021.
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 | K213629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2021 |
| Decision Date | February 12, 2023 |
| Days to Decision | 452 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. |