510(k) K192087 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Combo Electrotherapy Device
| Applicant | Shenzhen Roundwhale Technology Co. , Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Nov 1, 2019 |
| Received | Aug 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192087
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.