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LiteWalk Sandals
VIASONIX LTD · Model Medium · UDI-DI 07290016880274
1
510(k) clearances
38
Adverse events (1 deaths)
5
Recalls
100
Facilities
Description
The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located in the general regions of the heel, arch, metatarsals and toes. These chambers inflate sequentially to mimic the sequence of walking. The Medium size is in : US 6-8, EU 39-42. The sandals are made of Colored Fabric Material. The sandals are supplied not sterile and for a reusable single patient use.
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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