510(k) K163166 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
| Applicant | Easywell Biomedicals, Inc., Hsinchu, TW |
| Decision | Substantially Equivalent, Aug 11, 2017 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163166
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.