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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K925666
Device Name THERAPACER 3000
Applicant
Kvm Technologies, Inc.
9431 W. Sam Houston Pky.
South
Houston,  TX  77099
Applicant Contact JOHN F BERRY
Correspondent
Kvm Technologies, Inc.
9431 W. Sam Houston Pky.
South
Houston,  TX  77099
Correspondent Contact JOHN F BERRY
Regulation Number890.5380
Classification Product Code
BXB  
Date Received11/10/1992
Decision Date 03/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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