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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 K871802
Device Name MODEL K210 AND K211 FLUIDOTHERAPY UNITS
Applicant
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Applicant Contact ERNEST J HENLEY,PHD
Correspondent
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Correspondent Contact ERNEST J HENLEY,PHD
Regulation Number890.5100
Classification Product Code
LSB  
Date Received05/08/1987
Decision Date 09/04/1987
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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