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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K914142
Device Name HEMO-PULSE 2000
Applicant
Chrono Dynamics, Ltd.
6012 N. Dixie Dr.
Dayton,  OH  45414
Applicant Contact WILLIAM H REEVES
Correspondent
Chrono Dynamics, Ltd.
6012 N. Dixie Dr.
Dayton,  OH  45414
Correspondent Contact WILLIAM H REEVES
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/16/1991
Decision Date 01/03/1992
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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