510(k) K182671 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Medi-Direct TENS Pen
| Applicant | Jkh USA, LLC, Diamond Bar CA, US |
| Decision | Substantially Equivalent, Sep 21, 2019 |
| Received | Sep 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182671
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.