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510(k) K191312

Perfect PFE by Tenscare, Ltd. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2019
Date Received
May 15, 2019
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 Tenscare, Ltd.

  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K230926 — Ova+ (K-OVAP-USA) (December 15, 2023)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)
  • K231053 — Unicare (K-UNICARE-USA) (August 18, 2023)
  • K200694 — Perfect EMS (June 4, 2021)
  • K142506 — TensCare KegelFit (April 20, 2015)
  • K103698 — TENSCARE ITOUCH SURE MODEL ITS (June 21, 2011)
  • K082377 — TENSCARE ITOUCH MODEL(S) EASY AND PLUS (February 9, 2009)
  • K023997 — TENSCARE ULTIMA NMS/EMS (March 3, 2003)
  • K020846 — ULTIMA TENS XL-A1 (May 21, 2002)

Other clearances for product code KPI

  • 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)
  • 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)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)