ClearanceBrief
510(k) K260944 ยท IRP Massager, Powered Inflatable Tube

ManaCold Compression System

ApplicantManamed, LLC, Denton TX, US
DecisionSubstantially Equivalent, Aug 12, 2026
ReceivedMar 23, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260944

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.