Cleared Traditional

K962681 - ECOGEL 300 TENS GEL (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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

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