Cleared Traditional

K202317 - Li-Battery powered OTC TENS/EMS

K202317 is the FDA 510(k) clearance for Li-Battery powered OTC TENS/EMS by Everyway Medical Instruments Co.,Ltd. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K202317 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Nov 2020
Decision
88d
Days
Class 2
Risk

K202317 is an FDA 510(k) clearance for the Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806. 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, CN). The FDA issued a Cleared decision on November 13, 2020 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Everyway Medical Instruments Co.,Ltd devices

Submission Details

510(k) Number K202317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date November 13, 2020
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K202317.
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
K203574 · Hivox Biotek, Inc. · Mar 2021
Everyway Analog OTC TENS, model N103A/N302
K202849 · Everyway Medical Instruments Co.,Ltd · Dec 2020
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
K202470 · Everyway Medical Instruments Co.,Ltd · Nov 2020
Li-Battery powered OTC TENS/EMS Combination Stimulator
K201335 · Everyway Medical Instruments Co.,Ltd · Oct 2020
Transcutaneous Electronic Nerve Stimulator
K200237 · Shenzhen Kentro Medical Electronics Co., Ltd. · Oct 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
K191982 · Shenzhen Kentro Medical Electronics Co., Ltd. · Sep 2020