Cleared Special

CP Relief Wand Rx - TENS/NMES

K252236 · N & C Holdings, LLC · Neurology
Aug 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K252236 is an FDA 510(k) clearance for the CP Relief Wand Rx - TENS/NMES, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by N & C Holdings, LLC (Jefferson City, US). The FDA issued a Cleared decision on August 15, 2025, 29 days after receiving the submission on July 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K252236 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2025
Decision Date August 15, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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