510(k) K260230 ยท BWK Stimulator, Electro-Acupuncture
Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)
| Applicant | Suzhou Medical Appliance Factory, Suzhou, CN |
| Decision | Substantially Equivalent, Oct 22, 2026 |
| Received | Jan 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260230
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.