Cleared Traditional

K821523 - OMNI TENS

K821523 is an FDA 510(k) clearance for OMNI TENS, manufactured by Omni Intl., Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K821523 · Omni Intl., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
26d
Days
Class 2
Risk

K821523 is an FDA 510(k) clearance for the OMNI TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Omni Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1982 after a review of 26 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 Omni Intl., Inc. devices

FDA 510(k) Submission Details - K821523

510(k) Number K821523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1982
Decision Date June 16, 1982
Days to Decision 26 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
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 188
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K821523.
WRIGHT CARE
K823497 · Dow Corning Wright · Jan 1983
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K823002 · Tri W-G, Inc. · Nov 1982
NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K813501 · Empi · Dec 1981
NEUROMED SELECTRA #7720
K812704 · Medtronic Vascular · Oct 1981
NEUROPAC ULTRA I
K810593 · Medical Devices, Inc. · Mar 1981