Cleared Traditional

K110716 - EVERYWAY LOW BACK PAIN RELIEF SYSTEM (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110716 · Everyway Medical Instruments Co.,Ltd · Neurology device
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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

Submission Details

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
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.

Device Classification

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 226
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