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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 K931555
Device Name ARTROMOT K2 CPM
Applicant
Ormed Mfg., Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Applicant Contact DAVID SCHLERF
Correspondent
Ormed Mfg., Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Correspondent Contact DAVID SCHLERF
Regulation Number890.5380
Classification Product Code
BXB  
Date Received03/30/1993
Decision Date 01/31/1994
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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