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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K053266
Device Name MYOTRAC INFINITI
Applicant
THOUGHT TECHNOLOGY LTD.
2180 BELGRAVE AVE.
MONTREAL, QUEBEC,  CA H4A 2LB
Applicant Contact SURESH SUGIRTHARAJA
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
HCC  
Date Received11/23/2005
Decision Date 12/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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