510(k) K183215 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Focus TENS Therapy, Model PM710-M/-L
| Applicant | Omron Healthcare, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Sep 7, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183215
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.