Cleared Traditional

K111654 - FD TENS 2070

K111654 is an FDA 510(k) clearance for FD TENS 2070, manufactured by Fuji Dynamics , Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K111654 · Fuji Dynamics , Ltd. · Neurology device
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Mar 2012
Decision
262d
Days
Class 2
Risk

K111654 is an FDA 510(k) clearance for the FD TENS 2070. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Fuji Dynamics , Ltd. (Hong Kong, CN). The FDA issued a Cleared decision on March 1, 2012 after a review of 262 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 Fuji Dynamics , Ltd. devices

FDA 510(k) Submission Details - K111654

510(k) Number K111654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date March 01, 2012
Days to Decision 262 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
113d slower than avg
Panel avg: 149d · This submission: 262d
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 330
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K111654.
GEMORE TENS SYSTEM
K120569 · Gemore Technology Co, Ltd. · Jul 2012
ULTIMA NEO
K120054 · Pain Management Technologies · Jun 2012
JIAJIAN TENS
K112288 · Wuxi Jiajian Medical Instrument Co., Ltd. · May 2012
NEUROTECH PLUS
K112258 · Bio-Medical Research, Ltd. · Jan 2012
H-WAVE
K112485 · Electronic Waveform Lab, Inc. · Dec 2011
FD TENS 2050 OR SLIDE TENS MODEL FD2050
K111645 · Fuji Dynamics , Ltd. · Nov 2011