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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 K950755
Device Name FLEXMATE K500
Applicant
Breg, Inc.
1261 Liberty Way
Vista,  CA  92083
Applicant Contact BARBER
Correspondent
Breg, Inc.
1261 Liberty Way
Vista,  CA  92083
Correspondent Contact BARBER
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/17/1995
Decision Date 10/05/1995
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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