ClearanceBrief
510(k) K242964 ยท DWJ System, Thermal Regulating

Celsi Warmer

ApplicantHadleigh Health Technologies, Sausalito CA, US
DecisionSubstantially Equivalent, Jun 20, 2025
ReceivedSep 26, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242964

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.