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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K874801
Device Name ORTHODERM THERAPY BED
Applicant
Health Products, Inc.
15401 Vantage Pkwy. W.
#114
Houston,  TX  77032
Applicant Contact JACK H HESS
Correspondent
Health Products, Inc.
15401 Vantage Pkwy. W.
#114
Houston,  TX  77032
Correspondent Contact JACK H HESS
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/23/1987
Decision Date 02/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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