Cleared Traditional

K021794 - TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)

K021794 is an FDA 510(k) clearance for TATUNG TMD-26AX SERIES TENS, manufactured by Tatung Co.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K021794 · Tatung Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
227d
Days
Class 2
Risk

K021794 is an FDA 510(k) clearance for the TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) T.... Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Tatung Co. (Flagstaff, US). The FDA issued a Cleared decision on January 13, 2003 after a review of 227 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 Tatung Co. devices

FDA 510(k) Submission Details - K021794

510(k) Number K021794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2002
Decision Date January 13, 2003
Days to Decision 227 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 148d · This submission: 227d
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 231
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K021794.
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc. · Jan 2004
NEUROTECH BAXOLVE TYPE 294
K023913 · Bio-Medical Research, Ltd. · Aug 2003
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
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K020749 · Everyway Medical Instruments Co.,Ltd · Oct 2002