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510(k) K053266

MYOTRAC INFINITI by Thought Technology , Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2005
Date Received
November 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Thought Technology , Ltd.

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  • K201014 — MyOnyx System (January 13, 2021)
  • K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR (March 15, 2006)
  • 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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