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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 K122154
Model PPRT-01
Device Name POWERPLAY MUSCLE MASSAGER
Original Applicant
FIG, LLC
2839 harvest moon drive
orange park,  FL  32073
Original Contact joe adkins
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/20/2012
Decision Date 11/21/2012
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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