Home / 510(k) Clearances / K233576

510(k) K233576

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) by Shenzhen Konmed Technology Co., Ltd. — Product Code KPI

K233576 is an FDA 510(k) premarket notification submitted by Shenzhen Konmed Technology Co., Ltd. for the device "Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Shenzhen Konmed Technology Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2024
Date Received
November 7, 2023
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.

  • K260178 — Pelvic Muscle Trainer (KM510, KM516B) (June 18, 2026)
  • 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

  • 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)
  • 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)

FDA data resources