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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 K913227
Device Name JACE MODEL T300 TOE CPM DEVICE
Applicant
Thera Kinetics, Inc.
1300 Rt. 73, Suite 205
Mt. Laurel,  NJ  08054
Applicant Contact MARK KOZAK
Correspondent
Thera Kinetics, Inc.
1300 Rt. 73, Suite 205
Mt. Laurel,  NJ  08054
Correspondent Contact MARK KOZAK
Regulation Number890.5380
Classification Product Code
BXB  
Date Received07/22/1991
Decision Date 08/16/1991
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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