Cleared Special

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

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252236 · N & C Holdings, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
29d
Days
Class 2
Risk

K252236 is an FDA 510(k) clearance for the CP Relief Wand Rx - TENS/NMES. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by N & C Holdings, LLC (Jefferson City, US). The FDA issued a Cleared decision on August 15, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all N & C Holdings, LLC devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Vision28
Tom Renner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K252236.
actiTENS mini
K252767 · Sublimed · Jan 2026
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
TENSWave
K241228 · Zynex Medical Officer · Aug 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · Oriental Inspiration Limited · Apr 2024
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023
iRelieve Microcurrent Pain Relief System
K212618 · Fast Track Technologies, Inc. · Sep 2022