# K102115: Odfs Pace

- Pathway: 510(k) (Traditional)
- Applicant: Odstock Medical, Ltd.
- Decided: Mar 30, 2011 after 245 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: 3 generations back to K800380 (1980). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951951: Focus Model 795 Unit, Empi (1996) Summary page 2.
- K050991: The Odfs Dropped Foot Stimulator, Department of Medical Physics and Biomedical Eng. (2005)

## Most influential descendants
- K123972: Walkaide System (2013), 14 descendants of its own
- K140886: Walkaide System (2014), 10 descendants of its own
- K162407: L300 Go System (2017), 9 descendants of its own
- K173682: L300 Go System (2018), 7 descendants of its own
- K190285: L300 Go System (2019), 5 descendants of its own

## Indications for use
The ODES® Pace 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 ODES® Pace 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/K102115
Methodology: https://510kreport.com/methodology