Cleared Traditional

K162744 - Everyway OTC EMS

K162744 is an FDA 510(k) clearance for Everyway OTC EMS, manufactured by Everyway Medical Instrument Co., Ltd.. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K162744 · Everyway Medical Instrument Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
307d
Days
Class 2
Risk

K162744 is an FDA 510(k) clearance for the Everyway OTC EMS, Model EV-805. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Everyway Medical Instrument Co., Ltd. (Shenkeng Dist, New Taipei City, TW). The FDA issued a Cleared decision on August 3, 2017 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Everyway Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K162744

510(k) Number K162744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date August 03, 2017
Days to Decision 307 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 115d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NGX Device Classification - Class 2, Special Controls

Product Code NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - NGX Stimulator, Muscle, Powered, For Muscle Conditioning

All 103
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K162744.
Katalyst Mark 1 Muscle Stimulation System Model 2
K181199 · Katalyst, Inc. · Sep 2018
BTL 799-2
K180813 · BTL Industries, Inc. · Jun 2018
Silk'n MODEL H5003 device
K180279 · Home Skinovations , Ltd. · May 2018
AM-100
K163165 · BTL Industries, Inc. · Feb 2017
SLENDERTONE® Connect Abs, Type 570
K161974 · Bio-Medical Research, Ltd. · Nov 2016
Slendertone connect Abs
K151903 · Bio-Medical Research, Ltd. · Nov 2015