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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 K902707
Device Name MODEL 9000 AT ANKLE CPM DEVICE
Applicant
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact WILLIAM TOWNSEND
Correspondent
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact WILLIAM TOWNSEND
Regulation Number890.5380
Classification Product Code
BXB  
Date Received06/19/1990
Decision Date 07/25/1990
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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