510(k) K252552 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
| Applicant | Shenzhen Changkun Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 6, 2026 |
| Received | Aug 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252552
No recall in the FDA data names this 510(k).
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