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510(k) K883597

MYODAC by Thought Technology , Ltd. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1988
Date Received
August 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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  • 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)

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