Cleared Traditional

K102115 - ODFS PACE

K102115 is the FDA 510(k) clearance for ODFS PACE by Odstock Medical, Ltd.. It is a Class 2 Neurology device (product code GZI) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K102115 · Odstock Medical, Ltd. · Neurology device
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Mar 2011
Decision
245d
Days
Class 2
Risk

K102115 is an FDA 510(k) clearance for the ODFS PACE. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Odstock Medical, Ltd. (Salisbury, Wiltshire, GB). The FDA issued a Cleared decision on March 30, 2011 after a review of 245 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - 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.

View all Odstock Medical, Ltd. devices

Submission Details

510(k) Number K102115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2010
Decision Date March 30, 2011
Days to Decision 245 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 148d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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 - GZI Stimulator, Neuromuscular, External Functional

All 20
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K102115.
L300 Go System
K190285 · Bioness, Inc. · Mar 2019
L300 Go System
K173682 · Bioness, Inc. · Mar 2018
ODFS Pace XL
K171396 · Odstock Medical, Ltd. · Jan 2018
FORTE ES
K940759 · Chattanooga Group, Inc. · Mar 1995
ROCHE COBAS ARGOS 5 DIFF
K912615 · Roche Diagnostic Systems, Inc. · Sep 1991
SELECT NEUROMUSCULAR STIMULATORS
K903434 · Medtronic Vascular · Aug 1991