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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 K221443
Device Name PureLift Pro Plus
Applicant
Xtreem Pulse LLC
353 W. 29 St. Suite 3
New York,  NY  10001
Applicant Contact Andrew Barile
Correspondent
Xtreem Pulse LLC
353 W. 29 St. Suite 3
New York,  NY  10001
Correspondent Contact Andrew Barile
Regulation Number882.5890
Classification Product Code
NFO  
Date Received05/18/2022
Decision Date 10/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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