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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 K872815
Device Name TRANSJAW(TM)
Applicant
Vitek, Inc.
3143 Yellowstone Blvd.
Houston,  TX  77054
Applicant Contact KAREN A YOUNG
Correspondent
Vitek, Inc.
3143 Yellowstone Blvd.
Houston,  TX  77054
Correspondent Contact KAREN A YOUNG
Regulation Number890.5380
Classification Product Code
BXB  
Date Received07/16/1987
Decision Date 01/19/1988
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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