510(k) K230443 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
| Applicant | Jiangxi Royall Smart Technology Co., Ltd., Ganzhou, CN |
| Decision | Substantially Equivalent, May 22, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230443
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.