510(k) K163393 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
| Applicant | Hi-Dow International, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Aug 4, 2017 |
| Received | Dec 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163393
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.