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510(k) K171896

Feminine Personal Trainer (FPT) by Ralston Group — Product Code HIR

K171896 is an FDA 510(k) premarket notification submitted by Ralston Group for the device "Feminine Personal Trainer (FPT)". The FDA issued a decision of Substantially Equivalent on August 29, 2017. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2017
Date Received
June 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances for product code HIR

  • K252748 — Pelvic Floor Exerciser (PF01) (April 27, 2026)
  • K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (August 1, 2024)
  • K231875 — Vaginal Tactile Ultrasound Imager (February 22, 2024)
  • K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (December 29, 2023)
  • K231780 — Perifit Care+ (December 20, 2023)
  • K221476 — Perifit (February 10, 2023)
  • K213913 — leva Pelvic Health System (June 30, 2022)
  • K212655 — Flyte (September 21, 2021)
  • K212495 — Leva Pelvic Health System (September 8, 2021)
  • K210764 — Flyte (April 13, 2021)

FDA data resources