Cleared Traditional

K870667 - OMEGA T200

K870667 is the FDA 510(k) clearance for OMEGA T200 by Henley Intl.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K870667 · Henley Intl. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
62d
Days
Class 2
Risk

K870667 is an FDA 510(k) clearance for the OMEGA T200. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on April 22, 1987 after a review of 62 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 Henley Intl. devices

Submission Details

510(k) Number K870667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date April 22, 1987
Days to Decision 62 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 148d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 118
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K870667.
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
K871125 · Biomedical Life Systems, Inc. · Jun 1987
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
K871126 · Biomedical Life Systems, Inc. · Jun 1987
OMEGA T100
K870666 · Henley Intl. · Apr 1987
EMPI LOGIX MODEL 712 NMS, TENS
K870168 · Empi · Apr 1987
BACPAC (TM), MODEL 6500
K864968 · Medical Devices, Inc. · Mar 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular · Feb 1987