Cleared Traditional

K171396 - ODFS Pace XL

K171396 is an FDA 510(k) clearance for ODFS Pace XL, manufactured by Odstock Medical, Ltd.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K171396

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.

GZI Device Classification - Class 2, Special Controls

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

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