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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K190269
Device Name PureLift
Xtreem Pulse, LLC
353 W. 29 St., Suite 3
New York,  NY  10001
Applicant Contact Andrew Berile
IUVO Consulting, LLC
PO Box 56436
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number882.5890
Classification Product Code
Date Received02/08/2019
Decision Date 08/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No