Cleared Traditional

K181707 - Everyway Wireless TENS & EMS Unit

K181707 is an FDA 510(k) clearance for Everyway Wireless TENS & EMS Unit, 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 90-day FDA review.

K181707 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Sep 2018
Decision
90d
Days
Class 2
Risk

K181707 is an FDA 510(k) clearance for the Everyway Wireless TENS & EMS Unit. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Shenkeng District, New Taipei City, TW). The FDA issued a Cleared decision on September 26, 2018 after a review of 90 days - within the typical 510(k) review window.

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 - K181707

510(k) Number K181707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2018
Decision Date September 26, 2018
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K181707.
Heat Pain Pro
K181992 · Omron Healthcare, Inc. · Nov 2018
A6 OTC Pain Relief TENS
K182753 · Everyway Medical Instruments Co.,Ltd · Oct 2018
V2 OTC Pain Relief TENS
K182767 · Everyway Medical Instruments Co.,Ltd · Oct 2018
ThermaCare Quick Therapy TENS
K181102 · Pfizer, Inc. · Sep 2018
Dual output digital therapy massager
K172834 · Shenzhen Osto Technology Co., Ltd. · Sep 2018
iStim S2 OTC Pain Relief TENS
K181849 · Everyway Medical Instruments Co., Ldt. · Aug 2018