K253790
- 510(k) number
- K253790
- Device name
- High Intensity Focused Electromagnetic Stimulation Device (FE60)
- Applicant
- Beijing Winkonlaser Technology Limited CN
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2026-08-13
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253790.pdf
Official FDA record: K253790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.