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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 149d · 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 Consultant

Regulatory Insight, Inc.
KEVIN WALLS

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 228
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K150308.
Counter OTC TENS Device, Model CSD-737Z
K151279 · Counter Scientific Development (Gz), Ltd. · Dec 2015
PainKARE
K151034 · Triowave Technologies · Nov 2015
Tyece OTC TENS Device
K150386 · Tyece , Ltd. · Nov 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
TENS AND POWERED MUSCLE STIMULATOR
K143268 · Shenzhen As-Tec Technology Co., Ltd. · Jul 2015