Cleared Traditional

K182671 - Medi-Direct TENS Pen

K182671 is an FDA 510(k) clearance for Medi-Direct TENS Pen, 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 360-day FDA review.

K182671 · Jkh USA, LLC · Neurology device
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Sep 2019
Decision
360d
Days
Class 2
Risk

K182671 is an FDA 510(k) clearance for the Medi-Direct TENS Pen. 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 September 21, 2019 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K182671

510(k) Number K182671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2018
Decision Date September 21, 2019
Days to Decision 360 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
212d slower than avg
Panel avg: 148d · This submission: 360d
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 K182671.
Combo Electrotherapy Device
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K182136 · Shenzhen Osto Technology Co., Ltd. · Oct 2019
Focus TENS Therapy, Model PM710-M/-L
K183215 · Omron Healthcare, Inc. · Sep 2019
GIM-STIM OTC TENS/EMS System
K190988 · Gemore Technology Co, Ltd. · Aug 2019
Mini TENS Therapy Device
K182871 · Shenzhen Jumper Medical Equipment Co., Ltd. · Aug 2019