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510(k) K260178

Pelvic Muscle Trainer (KM510, KM516B) by Shenzhen Konmed Technology Co., Ltd. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
January 21, 2026
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 Konmed Technology Co., Ltd.

  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K220161 — Biofeedback Nerve and Muscle Stimulator (July 20, 2022)
  • K202648 — Biofeedback Nerve and Muscle Stimulator (December 8, 2020)
  • K163288 — Pelvifine Pelvic Muscle Trainer (January 18, 2018)
  • K171722 — Electrodes with snap / Electrodes with pigtail (January 10, 2018)
  • K171721 — Electrodes with silver conductive (January 5, 2018)

Other clearances for product code KPI

  • K252601 — Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Tr (May 14, 2026)
  • K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (May 6, 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)