Cleared Traditional

K031546 - RAINBOW GT-4A PAIN RELIEF MACHINE

K031546 is an FDA 510(k) clearance for RAINBOW GT-4A PAIN RELIEF MACHINE, manufactured by Sino-Us Information, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K031546 · Sino-Us Information, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
181d
Days
Class 2
Risk

K031546 is an FDA 510(k) clearance for the RAINBOW GT-4A PAIN RELIEF MACHINE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Sino-Us Information, Inc. (Woodhaven, US). The FDA issued a Cleared decision on November 13, 2003 after a review of 181 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.

FDA 510(k) Submission Details - K031546

510(k) Number K031546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2003
Decision Date November 13, 2003
Days to Decision 181 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 149d · This submission: 181d
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 589
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K031546.
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
K032994 · Gemore Technology Co, Ltd. · Dec 2003
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
K032720 · Gemore Technology Co, Ltd. · Dec 2003
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
K031374 · Besmed Health Business Corp · Nov 2003
S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K033253 · Micro Current Technology, Inc. · Oct 2003
MEDS-4-INF+
K032055 · Medical Equipment Device Specialists · Oct 2003
E275
K032653 · Micro Current Technology, Inc. · Sep 2003
K031546 · RAINBOW GT-4A PAIN RELIEF MACHINE
Download PDF FDA Summary Sino-Us Information, …