WalkAide Unit
WalkAide is an external electrical stimulator for patients who cannot adequately lift the foot because of damage to upper motor neurons or spinal cord pathways. It stimulates ankle…
WalkAide is an external electrical stimulator for patients who cannot adequately lift the foot because of damage to upper motor neurons or spinal cord pathways. It stimulates ankle dorsiflexion during the swing phase of walking.
The unit attaches to a cuff just below the knee near the fibular head. It sends pulses through surface electrodes to the common peroneal nerve, activating the tibialis anterior and other muscles that lift the foot.
Listed Item
The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.
Control Module
The control module contains the electronics and uses one AA battery. A dial adjusts stimulation intensity. Stimulation can be triggered by the unit’s internal tilt sensor or by an optional foot or heel sensor. A clinician configures the system for the patient.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Suzhou Fast ATM Electric Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Netop Industrial Company Limited | Dongguan | Guangdong | Manufacturer | 14 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Guangzhou Longest Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 9 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
| Xemis Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Innovative Neurotronics Inc., United States |
|---|---|
| FDA product code | GZI |
| Device type | Stimulator, Neuromuscular, External Functional |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5810 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K140886 |
| Record published | 2016-08-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-0100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| L300 Go System | Bioness Medical, Inc. | 22 |
| RT300 | Restorative Therapies Inc. | 20 |
| H200 Wireless System | Bioness Medical, Inc. | 20 |
| Chattanooga | DJO, LLC | 17 |
| Cionic | Cionic | 6 |
| L100 Go System | Bioness Medical, Inc. | 4 |
| MyndStep | Myndtec Inc | 4 |
| ReGrasp | Rehabtronics, Inc. | 4 |
| XFT | Shenzhen XFT Medical Limited | 3 |
| RT200 | Restorative Therapies Inc. | 2 |
| RehaStim 2 | Hasomed Gmbh | 2 |
| H200 Wireless | Bioness Medical, Inc. | 2 |
Showing 12 of 53. All products under Stimulator, Neuromuscular, External Functional
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140886 | 2014-08-08 |
| K123972 | 2013-04-01 |
| K052329 | 2005-09-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-08-06 | Not classified | Nonconforming Material/Component | Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use. | 137 units | 2009-07-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.