Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)— 510(k) K252831
Substantially EquivalentDolanvy (Suzhou) Medical Technology Co., Ltd.
FDA 510(k) clearance K252831 for Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927), Substantially Equivalent on 2026-04-28. Applicant: Dolanvy (Suzhou) Medical Technology Co., Ltd.. Device class: 2.
Summary
Dolanvy (Suzhou) Medical Technology's Pelvic Floor Treatment Device is filed under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). The name lists eight models, DLR-8920 through DLR-8927.
Class II, 21 CFR 876.5320. It came in as a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
Dolanvy filed from Suzhou, China. Review took 235 calendar days (September 5, 2025 to April 28, 2026).
Clearance details
- Applicant
- Dolanvy (Suzhou) Medical Technology Co., Ltd.
- Product code
- Product code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code KPI
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