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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 K143197
Device Name Nice1
Applicant
Nice Recovery Systems, LLC
1382 Kalmia Ave.,
Boulder,  CO  80304
Applicant Contact MICHAEL ROSS
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plaza, Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received11/06/2014
Decision Date 12/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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