510(k) K211403 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
HIVOX OTC Electrical Stimulator, FT610-B
| Applicant | Hivox Biotek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Oct 15, 2021 |
| Received | May 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211403
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.