510(k) K212989 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Low-frequency Stimulator (Model: AST-645, AST-646)
| Applicant | Shenzhen Osto Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Nov 22, 2021 |
| Received | Sep 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212989
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.