510(k) K252831— Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)

Substantially Equivalent

Dolanvy (Suzhou) Medical Technology Co., Ltd.

Clearance details

Applicant: Dolanvy (Suzhou) Medical Technology Co., Ltd.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-05
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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