Cleared Traditional

K160115 - Heat Pain Pro

K160115 is the FDA 510(k) clearance for Heat Pain Pro by Omron Healthcare, Inc.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K160115 · Omron Healthcare, Inc. · Neurology device
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Jun 2016
Decision
136d
Days
Class 2
Risk

K160115 is an FDA 510(k) clearance for the Heat Pain Pro. 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 June 3, 2016 after a review of 136 days - within the typical 510(k) review window.

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 K160115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date June 03, 2016
Days to Decision 136 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
12d faster than avg
Panel avg: 148d · This submission: 136d
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

Promedic, Inc.
PAUL DRYDEN

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 138
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K160115.
EV-804 OTC Pain Relief TENS
K172919 · Everyway Medical Instruments Co.,Ltd · Apr 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · Bayer Healthcare, LLC · Mar 2018
Avail
K172079 · Omron Healthcare, Inc. · Oct 2017
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
MAXPOWER RELIEF
K141978 · Omron Healthcare, Inc. · Dec 2014
MODEL PM3030
K110068 · Omron Healthcare, Inc. · Dec 2011