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510(k) K252552

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) by Shenzhen Changkun Technology Co., Ltd. — Product Code KPI

K252552 is an FDA 510(k) premarket notification submitted by Shenzhen Changkun Technology Co., Ltd. for the device "Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)". The FDA issued a decision of Substantially Equivalent on May 6, 2026. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Shenzhen Changkun Technology Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2026
Date Received
August 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Shenzhen Changkun Technology Co., Ltd.

  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K231595 — Electric Breast Pump (October 26, 2023)
  • K221798 — Finger Pulse Oximeter, Model: X1906P (May 4, 2023)
  • K193387 — Arm Electronic Sphygmomanometer (January 27, 2021)
  • K193386 — Wrist Electronic Sphygmomanometer (January 27, 2021)
  • K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (June 17, 2020)

Other clearances for product code KPI

  • K260178 — Pelvic Muscle Trainer (KM510, KM516B) (June 18, 2026)
  • K252601 — Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Tr (May 14, 2026)
  • K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, (April 28, 2026)
  • K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0- (April 17, 2026)
  • K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P)) (February 12, 2026)
  • K251026 — Regenesis EMS Chair (August 29, 2025)
  • K243079 — NeuroTrac® MyoPlus Pro (MYO120U) (June 26, 2025)
  • K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) (March 27, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241899 — Pelvic Floor Stimulator (Intrelief PFE) (November 27, 2024)

FDA data resources