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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 K894353
Device Name ORTHODERM CONVERTIBLE
Applicant
Health Products, Inc.
747 Kenrick, #116
Houston,  TX  77060
Applicant Contact JACK H HESS
Correspondent
Health Products, Inc.
747 Kenrick, #116
Houston,  TX  77060
Correspondent Contact JACK H HESS
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received07/14/1989
Decision Date 08/09/1989
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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