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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 K895720
Device Name MOBILIMB J1 TMJ CPM UNIT
Applicant
Toronto Medical Corp.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Applicant Contact JEFF HARMON
Correspondent
Toronto Medical Corp.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Correspondent Contact JEFF HARMON
Regulation Number890.5380
Classification Product Code
BXB  
Date Received09/25/1989
Decision Date 01/04/1990
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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