510(k) K243289
K243289 is an FDA 510(k) premarket notification submitted by Nu Eyne Co., Ltd. for the device "ADDNOX (BPSPM1)". The FDA issued a decision of Substantially Equivalent on January 16, 2025. The device falls under product code QGL (Transcutaneous Nerve Stimulator For Adhd), a Class II device regulated under 21 CFR 882.5898. Nu Eyne Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2025
- Date Received
- October 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcutaneous Nerve Stimulator For Adhd
- Device Class
- Class II
- Regulation Number
- 882.5898
- Review Panel
- NE
- Submission Type
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.