Cleared Traditional

S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (K033253) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033253 · Micro Current Technology, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
13d
Days
Class 2
Risk

K033253 is an FDA 510(k) clearance for the S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Micro Current Technology, Inc. (Seattle, US). The FDA issued a Cleared decision on October 21, 2003 after a review of 13 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 Micro Current Technology, Inc. devices

Submission Details

510(k) Number K033253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2003
Decision Date October 21, 2003
Days to Decision 13 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 148d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 43
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K033253.
ClearUP Sinus Pain Relief
K182025 · Tivic Health Systems, Inc. · Jan 2019
BioWaveGO
K180943 · Biowave Corporation · Aug 2018
TENS device-EmeTerm, CinvStop
K172478 · Wat Medical Technology (Ningbo) Co., Ltd. · Apr 2018
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991
TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989