Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)— 510(k) K252552
Substantially EquivalentShenzhen 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.. Device class: 2.
Summary
Shenzhen Changkun Technology's Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) is filed under KPI, non-implantable electrical stimulators for incontinence.
Class II, 21 CFR 876.5320. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Changkun filed from Shenzhen, China. The decision came 266 calendar days after receipt (August 13, 2025 to May 6, 2026).
Clearance details
- Applicant
- Shenzhen Changkun 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
- Shenzhen, CN
Recent devices under product code KPI
view all- K262353 — BTL-299-F
- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252601 — Pelvic Muscle Trainer (4 models)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from Shenzhen Changkun Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.