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510(k) K964526

LIBERTY RECTAL PELVIC FLOOR EXERCISER by Utah Medical Products, Inc. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
November 12, 1996
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 Utah Medical Products, Inc.

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  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (January 23, 2013)
  • K101535 — BT-CATH (January 11, 2011)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (July 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)

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  • 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)