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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 K912526
Device Name GS-220 HAND IMPAIRMENT EVALUATION SYSTEM
Applicant
J-Tech, Inc.
553 Cobblestone Dr.
Midvale,  UT  84047
Applicant Contact TRACH LIVINGSTON
Correspondent
J-Tech, Inc.
553 Cobblestone Dr.
Midvale,  UT  84047
Correspondent Contact TRACH LIVINGSTON
Regulation Number888.1240
Classification Product Code
LBB  
Date Received06/07/1991
Decision Date 09/05/1991
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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