Not Cleared Post-NSE

DEN100024 - ZAP-IT! (FDA 510(k) Clearance)

Class II Neurology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN100024 · Ecobrands , Ltd. · Neurology device
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Nov 2014
Decision
1520d
Days
Class 2
Risk

DEN100024 is an FDA 510(k) submission (not cleared) for the ZAP-IT!. Classified as Piezo-electric Stimulator For Relief Of Mosquito Bite Itch (product code OSG), Class II - Special Controls.

Submitted by Ecobrands , Ltd. (Greenwood Village, US). The FDA issued a Not Cleared (DENG) decision on November 7, 2014 after a review of 1520 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5894 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1520 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ecobrands , Ltd. devices

Submission Details

510(k) Number DEN100024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 09, 2010
Decision Date November 07, 2014
Days to Decision 1520 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1372d slower than avg
Panel avg: 148d · This submission: 1520d
Pathway characteristics

Device Classification

Product Code OSG Piezo-electric Stimulator For Relief Of Mosquito Bite Itch
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5894
Definition Relief / Reduction Of Mosquito Bite Itch
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.