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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 K922940
Device Name CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002
Applicant
Exos, Inc.
2a Gill St.
Woburn,  MA  01801
Applicant Contact BETH MARCUS
Correspondent
Exos, Inc.
2a Gill St.
Woburn,  MA  01801
Correspondent Contact BETH MARCUS
Regulation Number888.1240
Classification Product Code
LBB  
Date Received06/18/1992
Decision Date 10/05/1992
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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