510(k) K252552

Device
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
Applicant
Shenzhen Changkun Technology Co., Ltd.
510(k) number
K252552
Product code
KPI
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-06
Date received
2025-08-13
Regulation
876.5320
Classification name
Stimulator, Electrical, Non-Implantable, For Incontinence
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Qingpeng Wang
Address
Rm. 101, Bldg. 1, 15 Xiusheng 2nd Rd., Xiuxin Community Kengzi Subdistrict, Pingshan District Shenzhen CN 518118 518118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.2026-05-14
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K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe ElectrodesZmi Electronics , Ltd.2024-01-18
K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.2023-10-20
K230780MFG-05Zimmer Medizinsysteme GmbH2023-10-05
K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.2023-09-21