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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 K854354
Device Name THE BLEDSOE PASSIVE MOTION EXERCISER
Applicant
Medical Technology and Innovations, Inc.
2609 Aero Dr.
Grand Prairie,  TX  75051
Applicant Contact GARY R BLEDSOE
Correspondent
Medical Technology and Innovations, Inc.
2609 Aero Dr.
Grand Prairie,  TX  75051
Correspondent Contact GARY R BLEDSOE
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/29/1985
Decision Date 02/06/1986
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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