510(k) K250146 ยท NGX Stimulator, Muscle, Powered, For Muscle Conditioning
SofWave System
| Applicant | Sofwave Medical, Ltd., Yokneam Iiit, IL |
| Decision | Substantially Equivalent, Apr 18, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250146
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.