Cleared Traditional

K150308 - Palm TENS

K150308 is an FDA 510(k) clearance for Palm TENS, manufactured by Heat IN A Click, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K150308 · Heat IN A Click, LLC · Neurology device
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Oct 2015
Decision
253d
Days
Class 2
Risk

K150308 is an FDA 510(k) clearance for the Palm TENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Heat IN A Click, LLC (Dania, US). The FDA issued a Cleared decision on October 20, 2015 after a review of 253 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 Heat IN A Click, LLC devices

FDA 510(k) Submission Details - K150308

510(k) Number K150308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2015
Decision Date October 20, 2015
Days to Decision 253 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 148d · This submission: 253d
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 150
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150308.
Electronic Pulse Stimulator
K160508 · Beijing Choice Electronic Technololgy Co., Ltd. · Nov 2016
Heat Pain Pro
K160115 · Omron Healthcare, Inc. · Jun 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