# K171396: ODFS Pace XL

- Pathway: 510(k) (Traditional)
- Applicant: Odstock Medical, Ltd.
- Decided: Jan 31, 2018 after 265 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800380 (1980). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102115: Odfs Pace, Odstock Medical, Ltd. (2011) Summary page 5.
- K050991: The Odfs Dropped Foot Stimulator, Department of Medical Physics and Biomedical Eng. (2005) Summary page 5.

## Indications for use
The ODFS® Pace XL is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. By detecting the swing phase of gait through a foot switch signal, appropriate electrical stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or impaired function. There may be additional benefits from FES such as muscle re-education, prevention/retardation of disuse atrophy, increased or maintained range of joint motion and increase in local blood flow. The ODFS® Pace XL is a medical device and should only be used under medical supervision for the treatment of dropped foot following an upper motor neuron injury.

Source page: https://510kreport.com/device/K171396
Methodology: https://510kreport.com/methodology