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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 K262861
Device Name PureLift Pro Max
Applicant
Xtreem Pulse, LLC
690 Washignton St.
Sutie 4b
New York,  NY  10001
Applicant Contact Jackie Schmainda
Correspondent
Xtreem Pulse, LLC
690 Washignton St.
Sutie 4b
New York,  NY  10001
Correspondent Contact Jackie Schmainda
Regulation Number882.5890
Classification Product Code
NFO  
Date Received08/13/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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