Cleared Traditional

K183215 - Focus TENS Therapy

K183215 is the FDA 510(k) clearance for Focus TENS Therapy by Omron Healthcare, Inc.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K183215 · Omron Healthcare, Inc. · Neurology device
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Sep 2019
Decision
292d
Days
Class 2
Risk

K183215 is an FDA 510(k) clearance for the Focus TENS Therapy, Model PM710-M/-L. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Lake Forest, US). The FDA issued a Cleared decision on September 7, 2019 after a review of 292 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 Omron Healthcare, Inc. devices

Submission Details

510(k) Number K183215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date September 07, 2019
Days to Decision 292 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
144d slower than avg
Panel avg: 148d · This submission: 292d
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.

Regulatory Consultant

Experien Group
Ronald S. Warren

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 - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K183215.
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Medi-Direct TENS Pen
K182671 · Jkh USA, LLC · 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
Transcutaneous Electrical Nerve Stimulator
K183288 · Shenzhen Kentro Medical Electronics Co., Ltd. · Jul 2019