LiteWalk

GUDID 07290016880250

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

VIASONIX LTD

Sequential venous compression system

• Primary Device ID: 07290016880250
• NIH Device Record Key: 33ce01c7-d3d1-433a-af5a-b4be693d4a98
• Commercial Distribution Discontinuation: 2020-06-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LiteWalk
• Version Model Number: LiteWalk
• Company DUNS: 533070236
• Company Name: VIASONIX LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016880250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192607

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-29
• Device Publish Date: 2020-06-19

Devices Manufactured by VIASONIX LTD

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• 07290016880496 - Pressure Cuff Size 2.5: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880502 - Pressure Cuff Size 1.9: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880519 - Pressure Cuff Size 1.6: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880526 - Pressure Cuff Size 7: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880465 - Pressure Cuff Size 10: 2023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure