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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 K920686
Device Name ORTHO-PLEX-REHABILITATION SYSTEM
Applicant
Plexus Intl., Inc.
2216 Pech Rd., P.O Box 801087
Houston,  TX  77055
Applicant Contact CARL H DUKE
Correspondent
Plexus Intl., Inc.
2216 Pech Rd., P.O Box 801087
Houston,  TX  77055
Correspondent Contact CARL H DUKE
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/14/1992
Decision Date 06/11/1992
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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