510(k) K190009 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
| Applicant | Hong Qiangxing (Shenzhen) Electronics Limited, Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 2, 2019 |
| Received | Jan 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190009
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.