510(k) K161537 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
OTC TENS Device, Model PTS-IV
| Applicant | Counter Scientific Development (Gz), Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Oct 13, 2016 |
| Received | Jun 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161537
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.