Not Cleared Post-NSE

DEN110009 - RESTLESS LEG DEVICE (FDA 510(k) Clearance)

Class I Neurology device.

DEN110009 · Mary M. Sorg (An Individual) Dba PJ Sleeper'S · Neurology device
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Dec 2013
Decision
1056d
Days
Class 1
Risk

DEN110009 is an FDA 510(k) submission (not cleared) for the RESTLESS LEG DEVICE. Classified as Foot Wrap For Treating Restless Leg Syndrome Symptoms (product code OTX), Class I - General Controls.

Submitted by Mary M. Sorg (An Individual) Dba PJ Sleeper'S (Waterford, US). The FDA issued a Not Cleared (DENG) decision on December 18, 2013 after a review of 1056 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5760 - 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 1056 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 Mary M. Sorg (An Individual) Dba PJ Sleeper'S devices

Submission Details

510(k) Number DEN110009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 27, 2011
Decision Date December 18, 2013
Days to Decision 1056 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
908d slower than avg
Panel avg: 148d · This submission: 1056d
Pathway characteristics

Device Classification

Product Code OTX Foot Wrap For Treating Restless Leg Syndrome Symptoms
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5760
Definition Applying Compression To The Muscles Of The Foot For The Purpose Of Affecting Nerve Impulses Sent To The Central Nervous System.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.