510(k) K171026 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Mytens Model: BW-TSX
| Applicant | Bewell Connect Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Nov 1, 2017 |
| Received | Apr 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171026
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.