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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 K925651
Device Name LIFE ISLAND 21
Applicant
Keisei (Usa) Co., Ltd.
23717 Hawthorne Blvd., #305
Torrance,  CA  90505
Applicant Contact YUJI FUNAI
Correspondent
Keisei (Usa) Co., Ltd.
23717 Hawthorne Blvd., #305
Torrance,  CA  90505
Correspondent Contact YUJI FUNAI
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/09/1992
Decision Date 07/27/1993
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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