Who else makes this device?

Name: WalkAide Kit for Demo Use
Brand: WalkAide Kit for Demo Use

Neurology › TherapeuticStimulator, Neuromuscular, External Functional

WalkAide Kit for Demo Use

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…

Registry build 21.09.26

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.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item

8manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

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.

Chinese manufacturers registered for FDA product code GZI
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

Regulatory record for WalkAide Kit for Demo Use
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

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment humidity 0 to 95 % RH; Storage environment temperature -4 to 140 °F; Handling environment humidity 0 to 95 % RH; Handling environment temperature 32 to 104 °F

Catalogue Numbers

Catalogue numbers for WalkAide Kit for Demo Use
Catalogue number	Size	Status
20-1002		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Recalls referencing this product code
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.