Home / 510(k) Clearances / K925681

510(k) K925681

MYOTRAC2D/CS by Thought Technology , Ltd. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
October 13, 1992
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 Thought Technology , Ltd.

  • K213197 — MyOnyx System (June 17, 2022)
  • K201014 — MyOnyx System (January 13, 2021)
  • K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR (March 15, 2006)
  • K053266 — MYOTRAC INFINITI (December 29, 2005)
  • K932149 — THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE (May 11, 1995)
  • K935213 — INCONTROL (May 11, 1995)
  • K915858 — MYOTRAC2 (September 9, 1992)
  • K915859 — MYOTRAC/S, MYODAC/S (September 9, 1992)
  • K913898 — MYOTRAC+/S, MYODAC+/S (March 26, 1992)
  • K903497 — FLEXCOMP DSP & PROCOMP (February 12, 1991)

Other clearances for product code HIR

  • 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)
  • K193364 — Intimate Rose Kegel Exercise System (August 24, 2020)