510(k) K231423 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
| Applicant | Shenzhen Roundwhale Technology Co. , Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 22, 2024 |
| Received | May 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231423
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.