510(k) K253790 ยท NGX Stimulator, Muscle, Powered, For Muscle Conditioning
High Intensity Focused Electromagnetic Stimulation Device (FE60)
| Applicant | Beijing Winkonlaser Technology Limited, Beijing, CN |
| Decision | Substantially Equivalent, Aug 13, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253790
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.