Cleared Traditional

K182203 - JKH Stimulator Plus

K182203 is an FDA 510(k) clearance for JKH Stimulator Plus, manufactured by Jkh USA, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K182203 · Jkh USA, LLC · Neurology device
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Mar 2019
Decision
211d
Days
Class 2
Risk

K182203 is an FDA 510(k) clearance for the JKH Stimulator Plus. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Jkh USA, LLC (Diamond Bar, US). The FDA issued a Cleared decision on March 14, 2019 after a review of 211 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jkh USA, LLC devices

FDA 510(k) Submission Details - K182203

510(k) Number K182203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date March 14, 2019
Days to Decision 211 days
Submission Type Traditional
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
63d slower than avg
Panel avg: 148d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
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 Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K182203.
MHD TENS
K190115 · Minghuangda Electronic Co., Ltd. · Jun 2019
Portable Electro-Stimulation Therapy Device
K182108 · Guangzhou Longest Science & Technology Co., Ltd. · Apr 2019
HIVOX OTC Electrical Stimulator
K190347 · Hivox Biotek, Inc. · Mar 2019
PAT (Pain Alleviation Technologies)
K182267 · Marchan Medical, LLC · Feb 2019
Maxpower Relief
K182120 · Omron Healthcare, Inc. · Jan 2019
Neck Care Therapy, Model: SYK 509B
K172897 · Shenzhen Osto Technology Co., Ltd. · Dec 2018