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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 K232001
Device Name Nu Skin RenuSpa iO
Applicant
Nse Products, Inc.
75 W. Center St.
Provo,  UT  84601 4432
Applicant Contact McKay Noll
Correspondent
Methodize, Inc.
24813 Cty 18
Nevis,  MN  56467
Correspondent Contact Jack Slovick
Regulation Number882.5890
Classification Product Code
NFO  
Date Received07/05/2023
Decision Date 11/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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