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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 K113275
Model POWER Q1000 PREMIUM
Device Name COMPRESSIBLE LIMB THERAPY SYSTEM
Original Applicant
WONJINMULSAN CO., LTD.
d-524 migun techno world 2
533-1 yongsan-dongyuseong-gu
daejeon,  KS ks
Original Contact eileen yang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/04/2011
Decision Date 02/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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