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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K850573
Device Name CURAMED 402
Applicant
Fluidotherapy Corp.
6113 Aletha Ln.
Houston,  TX  77081
Applicant Contact ERNEST J HENLEY
Correspondent
Fluidotherapy Corp.
6113 Aletha Ln.
Houston,  TX  77081
Correspondent Contact ERNEST J HENLEY
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received02/13/1985
Decision Date 05/17/1985
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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