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510(k) K230767

Pelvic Floor Muscle Stimulator by Nanjing Vishee Medical Technology Co., Ltd. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2023
Date Received
March 20, 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 Nanjing Vishee Medical Technology Co., Ltd.

  • K222875 — Powered Muscle Stimulator (Model name:MagGraver F200) (March 9, 2023)

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)
  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl (January 18, 2024)