Pelvic Muscle Trainer (KM510, KM516B)— 510(k) K260178

Substantially Equivalent

Shenzhen Konmed Technology Co., Ltd.

FDA 510(k) clearance K260178 for Pelvic Muscle Trainer (KM510, KM516B), Substantially Equivalent on 2026-06-18. Applicant: Shenzhen Konmed Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Konmed Technology Co., Ltd.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 2026-01-21
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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