Cleared Traditional

K191982 - Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) (FDA 510(k) Clearance)

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

K191982 · Shenzhen Kentro Medical Electronics Co., Ltd. · Neurology device

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Sep 2020

Decision

428d

Days

Class 2

Risk

K191982 is an FDA 510(k) clearance for the Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2.... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Kentro Medical Electronics Co., Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on September 25, 2020 after a review of 428 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Shenzhen Kentro Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K191982 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 25, 2019
Decision Date	September 25, 2020
Days to Decision	428 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

280d slower than avg

Panel avg: 148d · This submission: 428d

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.