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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 K920860
Device Name CONTROLLED PASSIVE MOTION MACHINE
Applicant
U.S. Mfg. & Management, Inc.
100 Fifth St.
Shelby Sq. Suite One
Bristol,  TN  37620
Applicant Contact RAND WATSON
Correspondent
U.S. Mfg. & Management, Inc.
100 Fifth St.
Shelby Sq. Suite One
Bristol,  TN  37620
Correspondent Contact RAND WATSON
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/25/1992
Decision Date 04/02/1992
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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