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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 K914860
Device Name SUTTER MODEL 10000 LEG CPM DEVICE
Applicant
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact WILLIAM M TOWNSEND
Correspondent
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact WILLIAM M TOWNSEND
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/29/1991
Decision Date 01/08/1992
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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