LiteWalk

The LiteWalk is Intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where…

Registry build 21.09.26

The LiteWalk is Intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied. The system is based on a pneumatic unit that includes a pump, valves, pressure sensor and tubing, and is fed by an external power supply of 12V DC. The LiteWalk doesn’t contains a software user interface. The 2 sandals (right/left) are inflated together at the same time with the same pump. The inflation cycle is sequential, as follows: inflate heel, inflate arch, deflate heel, inflate metatarsals, deflate arch, inflate toes, deflate metatarsals, deflate toes

37manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (17), Fujian (10), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IRP
Manufacturer City Province Registered as Device types
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Shenzhen Yicai Health Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Zhangzhou Easepal Innovation Co., Ltd. Zhangzhou Fujian Contract manufacturer 7
Grandway Technology (Shenzhen) Limited Shenzhen Guangdong Contract manufacturer 6
Shanghai Youwen Medical Technology Co., Ltd. Shanghai Shanghai Contract manufacturer 2
Ryder Electronics (Xinfeng) Ltd. Ganzhou Jiangxi Contract manufacturer 1
Foshan Hongfeng Co., Ltd. Foshan Guangdong Contract manufacturer 24
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Fofo Medical Co., Ltd. Xiamen Fujian Exporter 18
Shenzhen Ruiyi Business Technology Co., Ltd. Shenzhen Guangdong Specification developer 13

Showing 12 of 37. All 37 manufacturers in China registered for Massager, Powered Inflatable Tube

Record

Regulatory record for LiteWalk
Listed by Viasonix Ltd., Israel
FDA product code IRP
Device type Massager, Powered Inflatable Tube
Device class Class 2
Regulation 21 CFR 890.5650
Establishment Manufacturer
510(k) K192607
Record published 2020-06-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries manufacturing date, serial number
Distribution end date 2020-06-19

Catalogue Numbers

Catalogue numbers for LiteWalk
Catalogue number Size Status
LiteWalk Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LF900 Daesung Maref Co., Ltd. 69
LX9max Daesung Maref Co., Ltd. 47
Game Ready Avanos Medical, Inc. 34
Compressible Limb Therapy System(LX7(V7)) Daesung Maref Co., Ltd. 30
VU Xiamen Weiyou Intelligent Technology Co., Ltd. 28
NormaTec Normatec Industries, LP 27
SP-2000 Daesung Maref Co., Ltd. 23
BioTab Vive Health LLC 23
Rapid Reboot Rapid Reboot Recovery Products 22
4 chamber sleeve Daesung Maref Co., Ltd. 21
SP-1000 Daesung Maref Co., Ltd. 19
Homedics FKA Distributing Co., LLC 18

Showing 12 of 230. All products under Massager, Powered Inflatable Tube

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K192607 2019-12-19

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer