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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 K922550
Device Name ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
Applicant
Verimed Holdings, Inc.
1401 E. Broward Blvd.
Suite 200
Fort Lauderdale,  FL  33301
Applicant Contact CHRISTOPHER J CHASE
Correspondent
Verimed Holdings, Inc.
1401 E. Broward Blvd.
Suite 200
Fort Lauderdale,  FL  33301
Correspondent Contact CHRISTOPHER J CHASE
Regulation Number888.1500
Classification Product Code
KQX  
Date Received05/29/1992
Decision Date 12/10/1992
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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