Cleared Traditional

K920266 - TENS MODEL 240Z

K920266 is an FDA 510(k) clearance for TENS MODEL 240Z, manufactured by Oms Medical Supplies, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K920266 · Oms Medical Supplies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
317d
Days
Class 2
Risk

K920266 is an FDA 510(k) clearance for the TENS MODEL 240Z. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Oms Medical Supplies, Inc. (Weymouth, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Oms Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K920266

510(k) Number K920266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date December 03, 1992
Days to Decision 317 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
169d slower than avg
Panel avg: 148d · This submission: 317d
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 252
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K920266.
K-STIM CLEAR
K922202 · Katecho, Inc. · May 1993
THERA PULSE A ELECTRO NERVE STIMULATOR
K925686 · Biomedical Life Systems, Inc. · Mar 1993
SD-602 SD MODE 11, SD-603 SD MOD 111
K925729 · Skylark Device Co., Ltd. · Jan 1993
TX-3 SD
K923934 · Skylark Device Co., Ltd. · Oct 1992
SD-605 SD II PROGRAM
K923935 · Skylark Device Co., Ltd. · Oct 1992
INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992