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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K904008
Device Name STAGE IV, AIR-FLUIDIZE BED
Applicant
Unique Flotation Systems, Inc.
121 Enterprise Ct.
Corona,  CA  91720
Applicant Contact ROBERT J NANGLE
Correspondent
Unique Flotation Systems, Inc.
121 Enterprise Ct.
Corona,  CA  91720
Correspondent Contact ROBERT J NANGLE
Regulation Number890.5160
Classification Product Code
INX  
Date Received08/29/1990
Decision Date 10/10/1990
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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