ClearanceBrief
510(k) K221384 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

ApplicantHivox Biotek, Inc., New Taipei City, TW
DecisionSubstantially Equivalent, Jun 11, 2022
ReceivedMay 13, 2022
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K221384

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.