Home / 510(k) Clearances / K925681

510(k) K925681

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

K925681 is an FDA 510(k) premarket notification submitted by Thought Technology , Ltd. for the device "MYOTRAC2D/CS". The FDA issued a decision of Substantially Equivalent on Sep 29, 1995. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Thought Technology , Ltd. has 21 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 29, 1995
Date Received
Oct 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
510(k)

Other clearances by Thought Technology , Ltd.

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

Other clearances for product code HIR

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

FDA data resources