510(k) K220283 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
| Applicant | Hong Qiangxing (Shenzhen) Electronics Limited, Shenzhen, CN |
| Decision | Substantially Equivalent, May 2, 2022 |
| Received | Feb 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220283
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.