Cleared Traditional

TENS device-EmeTerm 2, Model: YF-ZTY-E2 (K220503) - FDA 510(k) Clearance

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

K220503 · Wat Medical Technology, Inc. · Neurology device
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Apr 2022
Decision
60d
Days
Class 2
Risk

K220503 is an FDA 510(k) clearance for the TENS device-EmeTerm 2, Model: YF-ZTY-E2. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Wat Medical Technology, Inc. (Ningbo, CN). The FDA issued a Cleared decision on April 23, 2022 after a review of 60 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 Wat Medical Technology, Inc. devices

Submission Details

510(k) Number K220503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date April 23, 2022
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 42
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K220503.
iRelieve Microcurrent Pain Relief System
K212618 · Fast Track Technologies, Inc. · Sep 2022
StimOnTM Pain Relief System (GM2439)
K213802 · Gimer Medical Co., Ltd. · Aug 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K220578 · Bozhou Rongjian Medical Appliance Co., Ltd. · May 2022
Transcutaneous Electrical Nerve Stimulator
K202893 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jun 2021
TrueRelief Device
K202186 · Truerelief · Mar 2021
BioWaveGO RX
K210202 · Biowave Corporation · Feb 2021