510(k) K180956 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
| Applicant | Shenzhen Roundwhale Technology Co. , Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 7, 2018 |
| Received | Apr 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180956
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.