Cleared Traditional

K894964 - K-2 TENS OR MED TENS

K894964 is an FDA 510(k) clearance for K-2 TENS OR MED TENS, 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 139-day FDA review.

K894964 · Oms Medical Supplies, Inc. · Neurology device
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Jan 1990
Decision
139d
Days
Class 2
Risk

K894964 is an FDA 510(k) clearance for the K-2 TENS OR MED TENS. 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 January 4, 1990 after a review of 139 days - within the typical 510(k) review window.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K894964

510(k) Number K894964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date January 04, 1990
Days to Decision 139 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
10d faster than avg
Panel avg: 149d · This submission: 139d
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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K894964.
REBOX II (TENS)
K895183 · Rebox (Uk) , Ltd. · Jan 1990
MEC-I-TRON MINI, MODEL M-2
K895289 · Meyer Equipment Company, Inc. · Jan 1990
ACUSOURCE 600 (TENS)
K895977 · Microcurrent Research, Inc. · Jan 1990
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · Medical Devices, Inc. · Dec 1989
ULTIMA XS MICROCURRENT TENS
K895295 · American Imex · Nov 1989
TTS2800
K895161 · Henley Intl. · Oct 1989
K894964 · K-2 TENS OR MED TENS
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