510(k) K253408 ยท NGX Stimulator, Muscle, Powered, For Muscle Conditioning
CoolTone
| Applicant | Zimmer Medizinsysteme GmbH, Neu-Elm, DE |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253408
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.