ClearanceBrief
510(k) K242815 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

POCKET TENS (EP-300)

ApplicantHivox Biotek, Inc., New Taipei City, TW
DecisionSubstantially Equivalent, Dec 17, 2024
ReceivedSep 18, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242815

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.