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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Ac-Powered
510(k) Number K012492
Device Name KADANCE 2000
Applicant
KADA RESEARCH, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Applicant Contact HARVEY KNAUSS
Correspondent
KADA RESEARCH, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Correspondent Contact HARVEY KNAUSS
Regulation Number888.1240
Classification Product Code
LBB  
Date Received08/03/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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