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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K102320
Device Name COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
Applicant
Daesung Maref Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Applicant Contact BRANDON CHOI
Correspondent
Daesung Maref Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Correspondent Contact BRANDON CHOI
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/17/2010
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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