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510(k) K213197

MyOnyx System by Thought Technology , Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2022
Date Received
September 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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.

  • K201014 — MyOnyx System (January 13, 2021)
  • K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR (March 15, 2006)
  • 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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  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)