510(k) K252831 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
| Applicant | Dolanvy (Suzhou) Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Apr 28, 2026 |
| Received | Sep 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252831
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.