Cleared Traditional

K110716 - EVERYWAY LOW BACK PAIN RELIEF SYSTEM

K110716 is an FDA 510(k) clearance for EVERYWAY LOW BACK PAIN RELIEF SYSTEM, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K110716 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2011
Decision
217d
Days
Class 2
Risk

K110716 is an FDA 510(k) clearance for the EVERYWAY LOW BACK PAIN RELIEF SYSTEM. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Taipei Hsien, TW). The FDA issued a Cleared decision on October 18, 2011 after a review of 217 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 Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K110716

510(k) Number K110716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2011
Decision Date October 18, 2011
Days to Decision 217 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
69d slower than avg
Panel avg: 148d · This submission: 217d
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 219
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K110716.
PAIN-AID
K113037 · Pdi Works, LLC · Mar 2012
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K110068 · Omron Healthcare, Inc. · Dec 2011
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
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CARE BACK PAIN RELIEF STIMULATOR
K110707 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2011
PAIN BUDDY
K102051 · Biomedical Life Systems, Inc. · Jul 2011
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K091757 · Well-Life Healthcare Limited · Feb 2010