# K243289: Addnox (BPSPM1)

- Pathway: 510(k) (Traditional)
- Applicant: Nu Eyne Co., Ltd.
- Decided: Jan 16, 2025 after 90 days
- Product code: QGL (Transcutaneous Nerve Stimulator For Adhd)
- Device class: 2
- Regulation: 21 CFR 882.5898
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180041 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213629: SMILE, Nu Eyne Co., Ltd. (2023) Summary page 6.

## Indications for use
The ADDNOX is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

Source page: https://510kreport.com/device/K243289
Methodology: https://510kreport.com/methodology