Cleared Traditional

ADDNOX (BPSPM1)

K243289 · Nu Eyne Co., Ltd. · Neurology
Jan 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K243289 is an FDA 510(k) clearance for the ADDNOX (BPSPM1), 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 review panel. Regulated under 21 CFR 882.5898.

Submission Details

510(k) Number K243289 FDA.gov
FDA Decision Cleared 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

Device Classification

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.