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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K252236
Device Name CP Relief Wand Rx - TENS/NMES
Applicant
N & C Holdings, LLC
1709 Honey Creek Rd.
Jefferson City,  MO  65101
Applicant Contact Norm Schroeder
Correspondent
Vision28
915 SW Rimrock Way, Suite 201-402
Redmond,  OR  97756
Correspondent Contact Tom Renner
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received07/17/2025
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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