ClearanceBrief
510(k) K252396 · IRP Massager, Powered Inflatable Tube

Cryo Sport 2.0 (AVA 501)

ApplicantAvanutri Equipamentos DE Saúde, Tres Rios, BR
DecisionSubstantially Equivalent, May 29, 2026
ReceivedJul 31, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252396

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.