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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 K183169
Device Name Pulse 2.0, Pulse Pro 2.0
Applicant
NormaTec Industries, LP
480 Pleasant St., Suite A200
Watertown,  MA  02472
Applicant Contact Albert G. Sanford
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/16/2018
Decision Date 12/27/2018
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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