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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K875321
Device Name MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
Applicant
Kinetic Concepts, Inc.
P.O. Box 8588
San Antonio,  TX  78208
Applicant Contact A WEHRMEYER
Correspondent
Kinetic Concepts, Inc.
P.O. Box 8588
San Antonio,  TX  78208
Correspondent Contact A WEHRMEYER
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received12/29/1987
Decision Date 01/27/1988
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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