Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)— 510(k) K252552

Substantially Equivalent

Shenzhen Changkun Technology Co., Ltd.

FDA 510(k) clearance K252552 for Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303), Substantially Equivalent on 2026-05-06. Applicant: Shenzhen Changkun Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Changkun Technology Co., Ltd.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-13
Decision date: 2026-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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