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

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.

  • 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

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  • 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)
  • K234061 — StarFormer (July 1, 2024)
  • K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl (January 18, 2024)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)
  • K230780 — MFG-05 (October 5, 2023)