Home / 510(k) Clearances / K821664

510(k) K821664

PP-100, PERSONAL PERINEOMETER by Farrall Instruments, Inc. — Product Code HIR

K821664 is an FDA 510(k) premarket notification submitted by Farrall Instruments, Inc. for the device "PP-100, PERSONAL PERINEOMETER". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Farrall Instruments, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
May 28, 1982
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 by Farrall Instruments, Inc.

  • K940128 — CAT-400UL PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K821723 — BI-4520 DUAL IMPEDOMETER (September 15, 1982)
  • K792305 — A SLEEP ASSESSMENT DEVICE (December 20, 1979)
  • K781634 — VISUALAX (October 3, 1978)
  • K760166 — STIMULATOR, SONIC CONTROL (AS-1) (July 20, 1976)

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