Cleared Traditional

K200237 - Transcutaneous Electronic Nerve Stimulator (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200237 · Shenzhen Kentro Medical Electronics Co., Ltd. · Neurology device

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Oct 2020

Decision

269d

Days

Class 2

Risk

K200237 is an FDA 510(k) clearance for the Transcutaneous Electronic Nerve Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Kentro Medical Electronics Co., Ltd. (Longgang District, Shenzhen City, CN). The FDA issued a Cleared decision on October 19, 2020 after a review of 269 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 Shenzhen Kentro Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K200237 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 24, 2020
Decision Date	October 19, 2020
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

121d slower than avg

Panel avg: 148d · This submission: 269d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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.