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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 K890200
Device Name PNEUMATIC DORSIFLEXOR
Applicant
Medical Flotation Systems, Inc.
104 Elden St., Suite 11
Herndon,  VA  22070
Applicant Contact JACOBS, MD
Correspondent
Medical Flotation Systems, Inc.
104 Elden St., Suite 11
Herndon,  VA  22070
Correspondent Contact JACOBS, MD
Regulation Number890.5380
Classification Product Code
BXB  
Date Received01/18/1989
Decision Date 02/03/1989
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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