Cleared Traditional

K962681 - ECOGEL 300 TENS GEL

K962681 is an FDA 510(k) clearance for ECOGEL 300 TENS GEL, manufactured by Eco-Med Pharmaceuticals, Inc.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K962681 · Eco-Med Pharmaceuticals, Inc. · Neurology device
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Oct 1996
Decision
86d
Days
Class 2
Risk

K962681 is an FDA 510(k) clearance for the ECOGEL 300 TENS GEL. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Eco-Med Pharmaceuticals, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on October 4, 1996 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Eco-Med Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K962681

510(k) Number K962681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1996
Decision Date October 04, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 36
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K962681.
BATCH #6060 CONDUCTIVE GEL
K983964 · Skylark Device Co., Ltd. · Dec 1998
MODEL 1700, HYDRO PREP
K970694 · Physiometrix, Inc. · May 1997
HYDROPREP GEL
K964737 · D.O. Weaver Co. · Mar 1997
MEDI-TRACE DEFIB PADS
K955597 · Graphic Controls Corp. · Jul 1996
GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
K944598 · Chester Labs, Inc. · May 1996
GRAHAM-FIELD CONDUCTIVE ECG SPRAY
K944599 · Chester Labs, Inc. · May 1996