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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 K935808
Device Name REVOLUTION LOWER LIMB CPM UNIT
Applicant
Toronto Medical, Inc.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Applicant Contact BARBARA HOLT
Correspondent
Toronto Medical, Inc.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Correspondent Contact BARBARA HOLT
Regulation Number890.5380
Classification Product Code
BXB  
Date Received12/02/1993
Decision Date 03/18/1994
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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