510(k) K230164 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
TENS and EMS Stimulation (OTC)
| Applicant | Changsha Yuwen Medical Equipment Co., Ltd., Changsha, CN |
| Decision | Substantially Equivalent, Apr 10, 2023 |
| Received | Jan 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230164
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.