Cleared Abbreviated

K153704 - Strive

K153704 is an FDA 510(k) clearance for Strive, manufactured by Djo, LLC. The device is a Class 2 Neurology device with product code GZJ cleared through the Abbreviated 510(k) pathway after a 163-day FDA review.

K153704 · Djo, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
163d
Days
Class 2
Risk

K153704 is an FDA 510(k) clearance for the Strive. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Djo, LLC (Vista, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 163 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K153704

510(k) Number K153704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date June 03, 2016
Days to Decision 163 days
Submission Type Abbreviated
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
14d slower than avg
Panel avg: 149d · This submission: 163d
Pathway characteristics
Standards-based clearance path.

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 556
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K153704.
STIMPOD NMS460 Nerve Stimulator
K161091 · Xavant Technology (Pty), Ltd. · Jan 2017
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
SimulCare II(TM)
K160246 · Xanacare Technologies, LLC · Oct 2016
FD TENS 2090, FD TENS 2095
K152676 · Fuji Dynamics , Ltd. · Jan 2016
BiowaveHOME Neuromodulation Pain Therapy Device
K152437 · Biowave Corporation · Sep 2015
Synapse Transcutaneous Electrical Stimulation Device
K143198 · Synapse Electroceutical Limited · May 2015
K153704 · Strive
Download PDF FDA Summary Djo, LLC