Cleared Abbreviated

K020749 - DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS

K020749 is an FDA 510(k) clearance for DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE..., manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code GZJ cleared through the Abbreviated 510(k) pathway after a 238-day FDA review.

K020749 · Everyway Medical Instruments Co.,Ltd · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
238d
Days
Class 2
Risk

K020749 is an FDA 510(k) clearance for the DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Alpharetta, US). The FDA issued a Cleared decision on October 31, 2002 after a review of 238 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.

View all Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K020749

510(k) Number K020749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date October 31, 2002
Days to Decision 238 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
90d slower than avg
Panel avg: 148d · This submission: 238d
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 255
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K020749.
HIVOX DREAMATE DM-800
K021952 · Hivox Biotek, Inc. · May 2003
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · Biomedical Life Systems, Inc. · Nov 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · Biomedical Life Systems, Inc. · Nov 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
K020712 · Biomedical Life Systems, Inc. · Sep 2002
NT MEDITENS PLUS, TYPE 290
K014020 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · Apex Medical Corp. · Jun 2002