510(k) K193655 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
MSLS6QF TENS/PMS Device
| Applicant | Self Doctor Care, LLC, Frisco TX, US |
| Decision | Substantially Equivalent, Sep 4, 2020 |
| Received | Dec 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193655
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.