K243289
- 510(k) number
- K243289
- Device name
- ADDNOX (BPSPM1)
- Applicant
- Nu Eyne Co., Ltd. KR
- Product code
- QGL — Transcutaneous Nerve Stimulator For Adhd
- Decision date
- 2025-01-16
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243289.pdf
Official FDA record: K243289
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.