# K252552: Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changkun Technology Co., Ltd.
- Decided: May 6, 2026 after 266 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K891773 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141643: Yarlap, International Trade Group, Inc. (2015) Summary page 5.

## Indications for use
Pelvic Floor Rehabilitation Therapy Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress and urge urinary incontinence in women.

Source page: https://510kreport.com/device/K252552
Methodology: https://510kreport.com/methodology