Identity
- Trade Name
- LiteWalk FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- LiteWalk FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016880250 FDA UDI
- 510(k) Number
- K192607 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Sequential venous compression system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
LiteWalk by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Viasonix Ltd
Sources (1)
- FDA UDI 33ce01c7-d3d1-433a-af5a-b4be693d4a98 35 fields · synced May 31, 2026