Cleared Special

K252236 - CP Relief Wand Rx - TENS/NMES (FDA 510(k) Clearance)

Aug 2025
Decision
29d
Days
Class 2
Risk

K252236 is an FDA 510(k) clearance for the CP Relief Wand Rx - TENS/NMES. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K252236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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