510(k) K220997 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Wireless TENS/EMS, Bruno, Aela
| Applicant | Zmi Elecronics , Ltd., Kaohsiung, TW |
| Decision | Substantially Equivalent, Sep 1, 2022 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220997
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.