# K052329: Walkaide System, Models 20-0100, 20-0310, 20-1000

- Pathway: 510(k) (Special)
- Applicant: Innovative Neurotronics, Inc.
- Decided: Sep 21, 2005 after 27 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K800380 (1980). 5 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974514: External Functional Neuromuscular Stimulator, Neuromotion, Inc. (1998) Summary page 1.

## Most influential descendants
- K123972: Walkaide System (2013), 14 descendants of its own
- K140886: Walkaide System (2014), 10 descendants of its own
- K122784: Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000; Small Ness L300 System Kit, Right (2012), 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

## Recalls of this device
- Aug 6, 2008 · Not classified · Z-1435-2009: Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.

## Indications for use
The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) 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 System 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/K052329
Methodology: https://510kreport.com/methodology