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ODFS Pace XL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171396

by Odstock Medical, Ltd.

Identifiers

510(k) Number
K171396 FDA 510(k)
FDA Product Code
GZI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5810 FDA 510(k)
Regulation Number
882.5810 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ODFS Pace XL is a neuromuscular external functional stimulator designed for the treatment of dropped foot following an upper motor neuron injury. It is a medical device that provides functional electrical stimulation to improve foot dorsiflexion during walking.

The device is supplied as a kit and should only be set up by a person trained in the use of functional electrical stimulation. It is intended for prescription use under medical supervision. The ODFS Pace XL has FDA 510(k) clearance with product code GZI and is classified as a class II medical device.

Frequently asked questions

What is the ODFS Pace XL used for?

The ODFS Pace XL is a neuromuscular external functional stimulator designed specifically for the treatment of dropped foot following an upper motor neuron injury. It provides functional electrical stimulation to improve foot dorsiflexion during walking.

How is the ODFS Pace XL supplied and who can set it up?

The device is supplied as a kit and should only be set up by a person trained in the use of functional electrical stimulation. It is intended for prescription use under medical supervision to ensure proper application and effectiveness.

What is the regulatory status of the ODFS Pace XL?

The ODFS Pace XL has FDA 510(k) clearance with product code GZI and is classified as a class II medical device. It was cleared through the traditional review process by the Neurology advisory committee in 2018.

Is the ODFS Pace XL reusable or single-use?

The device information does not specify whether the ODFS Pace XL is reusable or single-use. This detail would be provided in the product instructions for use that accompanies the device kit.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ODFS® Pace | Odstock Medical, ODFS® Pace XL - Made in Britain, PDF 510(k) Summary Pace XL v5 - accessdata.fda.gov, ODFS Pace XL (K171396) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Odstock Medical, Ltd.

Sources (1)

  • FDA 510(k) K171396 24 fields · synced Sep 24, 2026