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510(k) K053434

MYOTRAC INFINITI ELECTRICAL STIMULATOR by Thought Technology , Ltd. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2006
Date Received
December 9, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Thought Technology , Ltd.

  • K213197 — MyOnyx System (June 17, 2022)
  • K201014 — MyOnyx System (January 13, 2021)
  • K053266 — MYOTRAC INFINITI (December 29, 2005)
  • K925681 — MYOTRAC2D/CS (September 29, 1995)
  • 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)

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