Cleared Traditional

K160246 - SimulCare II(TM)

K160246 is an FDA 510(k) clearance for SimulCare II(TM), manufactured by Xanacare Technologies, LLC. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K160246 · Xanacare Technologies, LLC · Neurology device
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Oct 2016
Decision
248d
Days
Class 2
Risk

K160246 is an FDA 510(k) clearance for the SimulCare II(TM). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Xanacare Technologies, LLC (Denver, US). The FDA issued a Cleared decision on October 6, 2016 after a review of 248 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 Xanacare Technologies, LLC devices

FDA 510(k) Submission Details - K160246

510(k) Number K160246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date October 06, 2016
Days to Decision 248 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 148d · This submission: 248d
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 166
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K160246.
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K172478 · Wat Medical Technology (Ningbo) Co., Ltd. · Apr 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
SENSUS
K130919 · Neurometrix, Inc. · Jul 2013
SENSUS
K121184 · Neurometrix, Inc. · Aug 2012
NEUROTECH PLUS
K112258 · Bio-Medical Research, Ltd. · Jan 2012