LiteWalk
VIASONIX LTD · Model LiteWalk · UDI-DI 07290016880250
Description
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
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | Zhejiang Luyao Electronics Technology Co., Ltd. | Regulatory documentation error and misleading color packaging claim. |
| 2023-03-07 | Compass Health Brands (Corporate Office) | Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indica |
| 2017-01-13 | Won Industry Co. | Distribution of unapproved devices with incorrect air compression level setup |
| 2017-01-13 | Won Industry Co. | Distribution of unapproved devices with incorrect air compression level setup |
| 2011-08-23 | CoolSystems, Inc. | It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finishe |
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