High Intensity Focused Electromagnetic Stimulation Device (FE60)— 510(k) K253790
Substantially EquivalentBeijing Winkonlaser Technology Limited
FDA 510(k) clearance K253790 for High Intensity Focused Electromagnetic Stimulation Device (FE60), Substantially Equivalent on 2026-08-13. Applicant: Beijing Winkonlaser Technology Limited. Device class: 2.
Summary
Beijing Winkonlaser Technology filed a High Intensity Focused Electromagnetic Stimulation Device, model FE60, under product code NGX, powered muscle stimulators for muscle conditioning.
Class II, 21 CFR 890.5850. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).
Winkonlaser filed from Beijing, China. The substantially equivalent decision came 258 calendar days after receipt (November 28, 2025 to August 13, 2026).
Clearance details
- Applicant
- Beijing Winkonlaser Technology Limited
- Product code
- Product code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
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