Cleared Traditional

K013210 - TRUWAVE

K013210 is an FDA 510(k) clearance for TRUWAVE, manufactured by Dan Med, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K013210 · Dan Med, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
190d
Days
Class 2
Risk

K013210 is an FDA 510(k) clearance for the TRUWAVE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Dan Med, Inc. (Denver, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 190 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 Dan Med, Inc. devices

FDA 510(k) Submission Details - K013210

510(k) Number K013210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2001
Decision Date April 04, 2002
Days to Decision 190 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 148d · This submission: 190d
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 141
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K013210.
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
APEX MEDICAL MINI TENS
K020032 · Apex Medical Corp. · Jan 2002
APEX MEDICAL LCD TENS-VII
K012643 · Apex Medical Corp. · Oct 2001
WINNER CM4 COMBINATION UNIT
K012848 · Rich-Mar Corp. · Oct 2001