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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 K003272
Device Name FLO-BOOT
Applicant
Discovery Group, LLC
8110 Westbury Dr.
Richmond,  VA  23229
Applicant Contact RICHARD J FREER
Correspondent
Discovery Group, LLC
8110 Westbury Dr.
Richmond,  VA  23229
Correspondent Contact RICHARD J FREER
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/18/2000
Decision Date 04/04/2001
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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