510(k) K190347 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
HIVOX OTC Electrical Stimulator
| Applicant | Hivox Biotek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Mar 15, 2019 |
| Received | Feb 14, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190347
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.