Cleared Traditional

K172919 - EV-804 OTC Pain Relief TENS

K172919 is an FDA 510(k) clearance for EV-804 OTC Pain Relief TENS, 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 206-day FDA review.

K172919 · Everyway Medical Instruments Co.,Ltd · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
206d
Days
Class 2
Risk

K172919 is an FDA 510(k) clearance for the EV-804 OTC Pain Relief TENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (New Taipei City, TW). The FDA issued a Cleared decision on April 19, 2018 after a review of 206 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 - K172919

510(k) Number K172919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2017
Decision Date April 19, 2018
Days to Decision 206 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 slower than avg
Panel avg: 148d · This submission: 206d
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 K172919.
Wireless Pain Relieve Device
K180331 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2018
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
K180956 · Shenzhen Roundwhale Technology Co. , Ltd. · Jun 2018
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K181207 · Everyway Medical Instruments Co., Ldt. · Jun 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · Bayer Healthcare, LLC · Mar 2018
Wireless Pain Relieve Device Model: LT5018C
K173462 · Shenzhen Dongdixin Technology Co., Ltd. · Dec 2017
HIVOX OTC Electrical Stimulator
K171803 · Hivox Biotek, Inc. · Nov 2017