Cleared Traditional

K172478 - TENS device-EmeTerm

K172478 is an FDA 510(k) clearance for TENS device-EmeTerm, manufactured by Wat Medical Technology (Ningbo) Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K172478 · Wat Medical Technology (Ningbo) Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
246d
Days
Class 2
Risk

K172478 is an FDA 510(k) clearance for the TENS device-EmeTerm, CinvStop. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Wat Medical Technology (Ningbo) Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on April 19, 2018 after a review of 246 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 Wat Medical Technology (Ningbo) Co., Ltd. devices

FDA 510(k) Submission Details - K172478

510(k) Number K172478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2017
Decision Date April 19, 2018
Days to Decision 246 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
98d slower than avg
Panel avg: 148d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

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 162
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K172478.
ReliefBand
K182960 · Reliefband Technologies, LLC · Jun 2019
ClearUP Sinus Pain Relief
K182025 · Tivic Health Systems, Inc. · Jan 2019
BioWaveGO
K180943 · Biowave Corporation · Aug 2018
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
K162663 · Well-Life Healthcare Limited · Jan 2017
NEUROTECH PLUS
K112258 · Bio-Medical Research, Ltd. · Jan 2012
KNEEHAB XP
K110350 · Bio-Medical Research, Ltd. · Aug 2011