Cleared Traditional

K151034 - PainKARE

K151034 is an FDA 510(k) clearance for PainKARE, manufactured by Triowave Technologies. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K151034 · Triowave Technologies · Neurology device
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Nov 2015
Decision
218d
Days
Class 2
Risk

K151034 is an FDA 510(k) clearance for the PainKARE. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Triowave Technologies (Fremont, US). The FDA issued a Cleared decision on November 21, 2015 after a review of 218 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 Triowave Technologies devices

FDA 510(k) Submission Details - K151034

510(k) Number K151034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2015
Decision Date November 21, 2015
Days to Decision 218 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
70d slower than avg
Panel avg: 148d · This submission: 218d
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 164
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K151034.
Heat Pain Pro
K160115 · Omron Healthcare, Inc. · Jun 2016
Quell
K152954 · Neurometrix, Inc. · Jan 2016
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · Bayer Healthcare, LLC · Dec 2015
EV-820 OTC Pain Relief TENS
K151479 · Everyway Medical Instruments Co.,Ltd · Oct 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
MAXPOWER RELIEF
K141978 · Omron Healthcare, Inc. · Dec 2014