Cleared Traditional

K050740 - MICROWARE 200

K050740 is an FDA 510(k) clearance for MICROWARE 200, manufactured by Microware, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K050740 · Microware, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
15d
Days
Class 2
Risk

K050740 is an FDA 510(k) clearance for the MICROWARE 200. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Microware, Inc. (Vancouver, US). The FDA issued a Cleared decision on April 6, 2005 after a review of 15 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.

FDA 510(k) Submission Details - K050740

510(k) Number K050740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2005
Decision Date April 06, 2005
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 149d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MICHELLE S LEE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 547
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K050740.
BIO-STIM KIT
K050174 · Skylark Device & Systems Co., Ltd. · Sep 2005
E-STIM II
K050435 · Lhasa Oms, Inc. · Sep 2005
INTERX5000
K042912 · Neuro Resource Group, Inc. · May 2005
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc. · Mar 2005
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
K042107 · Tung FU Electric Co., Ltd. · Mar 2005
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
K041388 · Biomedical Life Systems, Inc. · Nov 2004
K050740 · MICROWARE 200
Download PDF FDA Summary Microware, Inc.