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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Fluidotherapy
510(k) Number K896817
Device Name MODEL T11 FLUIDOTHERAPY UNIT
Applicant
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Applicant Contact J HENLEY,PHD
Correspondent
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Correspondent Contact J HENLEY,PHD
Regulation Number890.5100
Classification Product Code
LSB  
Date Received12/04/1989
Decision Date 01/18/1991
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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