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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
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