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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
Device Name POWERPLAY MUSCLE MASSAGER
Applicant
FIG, LLC
2839 HARVEST MOON DRIVE
ORANGE PARK,  FL  32073
Applicant Contact JOE ADKINS
Correspondent
FIG, LLC
2839 HARVEST MOON DRIVE
ORANGE PARK,  FL  32073
Correspondent Contact JOE ADKINS
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/20/2012
Decision Date 11/21/2012
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
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