510(k) K212377 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
| Applicant | Ningbo Medkinetic Medical Device Co., Ltd., Ningbo, CN |
| Decision | Substantially Equivalent, Apr 15, 2022 |
| Received | Aug 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212377
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.