Cleared Traditional

K041164 - L-TENS

K041164 is an FDA 510(k) clearance for L-TENS, manufactured by Fuji Dynamics Limited. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K041164 · Fuji Dynamics Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
17d
Days
Class 2
Risk

K041164 is an FDA 510(k) clearance for the L-TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Fuji Dynamics Limited (Hong Kong, CN). The FDA issued a Cleared decision on May 20, 2004 after a review of 17 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.

FDA 510(k) Submission Details - K041164

510(k) Number K041164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date May 20, 2004
Days to Decision 17 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
132d faster than avg
Panel avg: 149d · This submission: 17d
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 449
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K041164.
FENZIAN TREATMENT SYSTEM
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BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
EASY MED TN-28 C
K040253 · Easy Med Instrument Co., Ltd. · Apr 2004
K041164 · L-TENS
Download PDF FDA Summary Fuji Dynamics Limited