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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Nonpowered
510(k) Number K861396
Device Name HANDHELD DYNAMOMETER, MODEL #160 AND #111
Applicant
Spark Instruments & Academics, Inc.
P.O. Box 5123
Coralville,  IA  52241
Applicant Contact SMIDT, PH.D.
Correspondent
Spark Instruments & Academics, Inc.
P.O. Box 5123
Coralville,  IA  52241
Correspondent Contact SMIDT, PH.D.
Regulation Number888.1250
Classification Product Code
HRW  
Date Received04/15/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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