Cleared Traditional

K171396 - ODFS Pace XL

K171396 is the FDA 510(k) clearance for ODFS Pace XL by Odstock Medical, Ltd.. It is a Class 2 Neurology device (product code GZI) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K171396 · Odstock Medical, Ltd. · Neurology device
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Jan 2018
Decision
265d
Days
Class 2
Risk

K171396 is an FDA 510(k) clearance for the ODFS Pace XL. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Odstock Medical, Ltd. (Salisbury, GB). The FDA issued a Cleared decision on January 31, 2018 after a review of 265 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 K171396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date January 31, 2018
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 148d · This submission: 265d
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 19
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