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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K945630
Device Name LARGE MUSCLE STRENGTH GAUGE
Applicant
J-Tech, Inc.
324 W. 1120 N.
American Fork,  UT  84003
Applicant Contact TRACY LIVINGSTON
Correspondent
J-Tech, Inc.
324 W. 1120 N.
American Fork,  UT  84003
Correspondent Contact TRACY LIVINGSTON
Regulation Number888.1500
Classification Product Code
KQX  
Subsequent Product Code
LBB  
Date Received11/16/1994
Decision Date 05/10/1995
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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