ClearanceBrief
510(k) K231569 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

ManaFlexx 2 (model: MF002-RX, MF002-OTC)

ApplicantManamed, Inc., Las Vegas NV, US
DecisionSubstantially Equivalent, Nov 3, 2023
ReceivedMay 31, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231569

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.