# K974514: External Functional Neuromuscular Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Neuromotion, Inc.
- Decided: Feb 6, 1998 after 67 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: 1 generation back to K800380 (1980). 4 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920436: Medtronic Respond Iii Neuromuscular Stimulator, Medtronic Vascular (1992) Summary page 1.
- K903434: Select Neuromuscular Stimulators, Medtronic Vascular (1991) Summary page 1.
- K800380: Fes Orthosis Model NO. 2000, Empi (1980) Summary page 1.
- K813515: Veri/DFS TM #817, Verite (1982) Summary page 1.

## Most influential descendants
- K050991: The Odfs Dropped Foot Stimulator (2005), 20 descendants of its own
- 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
- K052329: Walkaide System, Models 20-0100, 20-0310, 20-1000 (2005), 16 descendants of its own

## Indications for use
The NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient’s gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Source page: https://510kreport.com/device/K974514
Methodology: https://510kreport.com/methodology