# K050991: The Odfs Dropped Foot Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Department of Medical Physics and Biomedical Eng.
- Decided: Jul 15, 2005 after 87 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: 2 generations back to K800380 (1980). 6 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 27 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.
- K974514: External Functional Neuromuscular Stimulator, Neuromotion, Inc. (1998) Summary page 2.

## Most influential descendants
- K053468: NESS L300 (2006), 17 descendants of its own
- K102115: Odfs Pace (2011), 16 descendants of its own
- K080219: Modification to:Ness L300 (2008), 16 descendants of its own
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) (2011), 15 descendants of its own
- K123972: Walkaide System (2013), 14 descendants of its own

## Indications for use
The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow. The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Source page: https://510kreport.com/device/K050991
Methodology: https://510kreport.com/methodology