Cleared Traditional

K040253 - EASY MED TN-28 C

K040253 is an FDA 510(k) clearance for EASY MED TN-28 C, manufactured by Easy Med Instrument Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K040253 · Easy Med Instrument Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
64d
Days
Class 2
Risk

K040253 is an FDA 510(k) clearance for the EASY MED TN-28 C. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Easy Med Instrument Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on April 8, 2004 after a review of 64 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 - K040253

510(k) Number K040253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2004
Decision Date April 08, 2004
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 149d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 383
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K040253.
L-TENS
K041164 · Fuji Dynamics Limited · May 2004
MODEL GST-1
K040193 · Medical Equipment Device Specialists · Apr 2004
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc. · Jan 2004
PREMIER PLUS
K032003 · American Imex · Jan 2004
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
K032928 · Mediphysics Pain Centers of America · Dec 2003