Cleared Traditional

K131956 - QUICK RELAX PRO

K131956 is an FDA 510(k) clearance for QUICK RELAX PRO, manufactured by Healthcare Innovations, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K131956 · Healthcare Innovations, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
301d
Days
Class 2
Risk

K131956 is an FDA 510(k) clearance for the QUICK RELAX PRO. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Healthcare Innovations, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on April 24, 2014 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Healthcare Innovations, LLC devices

FDA 510(k) Submission Details - K131956

510(k) Number K131956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date April 24, 2014
Days to Decision 301 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
153d slower than avg
Panel avg: 148d · This submission: 301d
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 158
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K131956.
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · Andon Health Co, Ltd. · Aug 2015
MAXPOWER RELIEF
K141978 · Omron Healthcare, Inc. · Dec 2014
OTC COMBO TENS/EMS SYSTEM
K141299 · Well-Life Healthcare Limited · Nov 2014
OTC PATCH
K133723 · Well-Life Healthcare Limited · Jan 2014
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2013
MINI PATCH
K121353 · Well-Life Healthcare Limited · Sep 2012