Cleared Traditional

K003487 - STIMATE N601 TENS

K003487 is an FDA 510(k) clearance for STIMATE N601 TENS, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K003487 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Jan 2001
Decision
72d
Days
Class 2
Risk

K003487 is an FDA 510(k) clearance for the STIMATE N601 TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Taipei Hsien,, TW). The FDA issued a Cleared decision on January 24, 2001 after a review of 72 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.

View all Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K003487

510(k) Number K003487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date January 24, 2001
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 148d · This submission: 72d
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

Center For Measurement Standards of Industrial
HSU CHANG

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 276
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K003487.
MULTI-STIM, MODEL MS-100
K001897 · Metron Medical Australia, Pty, Ltd. · Jun 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · Biomedical Life Systems, Inc. · Jun 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · Johari Electro-Tech Co. · Feb 2001
MEDISANA DIGITAL TENS
K994265 · Fuji Dynamics Limited · Jul 2000
FDTENS 2010
K994266 · Fuji Dynamics Limited · Jul 2000
ENDOR 2000
K984376 · T.C. Medical, Inc. · Jun 2000