510(k) K251974 ยท DWJ System, Thermal Regulating
Arctic Sun Temperature Management System (Model 5000)
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Oct 24, 2025 |
| Received | Jun 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251974
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.